2013 Fall Group Meeting – Dallas, TX NURSING DISCIPLINE MEETING OVERVIEW 2013 Fall Group Meeting – Dallas, TX

Wednesday, October 9, 2013 Nursing New Member Orientation / First-Time Attendees

7:00 a.m. – 8:00 a.m.

Special Symposium: Nursing Education and Clinical Trials Subcommittees Patient/Family and Professional Education in the Children’s Oncology Group

2:00 p.m. – 4:00 p.m.

Thursday, October 10, 2013 PRO-QoL Resource Center Meeting

12:00 noon – 1:00 p.m.

Nursing Evidence-Based Practice/Clinical Trials Interactive Session Featuring Special Presentations by the 2013 COG Nursing Discipline Evidence-Based Practice Project Teams

2:00 p.m. – 4:00 p.m.

Nursing Discipline Continuing Education and Plenary Session Featuring CEU Presentation: “Cytogenetics for the COG Nurse” (1.0 CEU) ® Joy Bartholomew, RN, FNP-BC, CPHON

4:00 p.m. – 6:00 p.m.

Nursing Steering Committee (closed meeting)

7:00 p.m. – 9:00 p.m.

Friday, October 11, 2013 Nursing Clinical Trials Subcommittee: Disease and Protocol Committee Nurses

8:00 a.m. – 9:00 a.m.

Nursing Research-Scholars Meeting

9:00 a.m. – 11:00 a.m.

2013 Fall Group Meeting – Dallas, TX CRA Steering Committee Chair- Susan Stork Tuesday, October 8, 2013 5:00 p.m. – 7:00 p.m. AGENDA

1. Future Planning a. Nominating Committee report 2. CRA Retention Study 3. COG Update Dr. Adamson 4. Regulatory Update Dr. Bomgaars, Shanila Faghfoor 5. SDC Update Dr. Devidas, Steven Jong, Smita Subramanian, Charlotte Wood 6. SDO Update Judy Everett 7. Biopath Center Update - Lisa Beaverson

2013 Fall Group Meeting – Dallas, TX Canadian Investigator Meeting Chairs: Jim Whitlock, Kathy Brodeur-Robb Tuesday Oct 8, 2013 7PM – 9PM Agenda 1. C17 Report Jim Whitlock / Kathy Brodeur-Robb a. Introduction of Executive Members, Council and Committees in Attendance

15 minutes

2. DVL Report a. Update on activities b. Relapse Registry

Sylvain Baruchel / Sally Jones

15 minutes

3. NCE Application a. Timelines b. New Partnership opportunities

David Malkin

5 minutes

4. SMO Report a. Audits/Inspections/Monitoring b. Regulatory Statistics

Jackie Halton/Ellen Morrison

10 minutes

5. Sponsorship of Cooperative Groups a. Current b. Pending c. Costs

Kathy Brodeur-Robb

10 minutes

6. LCH-IV Investigator meeting

Sally Jones

10 minutes

7. CCRA Data on Research Enrolment

Kathy Brodeur-Robb

5 minutes

8. CPAC Research Investment Data

Kathy Brodeur-Robb

5 minutes

9. MIBG Therapy update

Sylvain Baruchel

5 minutes

10. Proton Facility

Jim Whitlock

5 minutes

11. Nurse Practitioner CoP

Sue Zupanac

5 minutes

12. HRQoL in Neuroblastoma study

Carol Portwine

10 minutes

13. AAML1321/CAMN1072203 Trial of Nilotinib in Canada

15 minutes

2013 Fall Group Meeting – Dallas, TX CANCER CONTROL AND SUPPORTIVE CARE STEERING COMMITTEE Chair- Lillian Sung AGENDA CCL Steering Meeting (Lillian Sung) Wednesday, October 9, 2013 7:00 a.m. – 9:00 a.m.

CCL Breakout Sessions Wednesday, October 9, 2013 9:00 a.m. – 12:00 p.m. 1. Breakout #1: 9:00 a.m. – 10:30 a.m. a. Neurotoxicity (Nicole Ullrich, Kristina Hardy) b. ACCL1031 Training (Nathaniel Treister) c. Infectious Diseases (Brian Fisher) d. Anti-emetics (Lee Dupuis) 2. Breakout #2: 10:30 a.m. to 12:00 p.m. a. Neurotoxicity (Nicole Ullrich, Kristina Hardy) b. HRQL and Palliative Care (Donna Johnston) c. ACCL1034 PI Meeting (Danielle Zerr) d. Guideline Working Group (Lee Dupuis) e. Nutrition (Elena Ladas)

CCL Open Session Wednesday, October 9, 2013 2:00 p.m. – 4:00 p.m. 1. Introduction (2:00) 2. Infections/Mucositis Overview (Brian Fisher) (2:05) a. ACCL0934: RCT of Levofloxacin to Prevent Bacterial Infection (Sarah Alexander) b. ACCL0933: RCT of Caspofungin to Prevent Fungal Infection in AML (Brian Fisher) c. ACCL1034: RCT of Chlorhexidine to Reduce Bloodstream Infection (Danielle Zerr)

3. ACCL1333: Apixaban for Thrombosis Prevention (2:20) (Sarah O’Brien) 4. Neurotoxicity – Overview (Nicole Ullrich) (2:30) a. Neurocognition (2:35) i. ACCL0922: Phase II RCT of Modafinil for Neurocognitive Deficits (Nicole Ullrich) ii. ACCL10P1: Computerized Cognitive Training for Pediatric Brain Tumor Patients: A Pilot Study (Kristina Hardy) iii. AALL1131: Longitudinal, Computerized Assessment of Neurocognitive Functioning (Embedded study) (Kristina Hardy) b. Ototoxicity (2:55) i. ACCL0431: Randomized Trial of STS to Prevent Ototoxicity (David Freyer) 5. Palliative Care and Symptom Management (HRQL) Overview (Donna Johnston) (3:15) a. AAML1031: AML (Rajaram Nagarajan) 6. Adherence (3:25) a. ACCL1033: Medication Adherence in ALL (Smita Bhatia) 7. Reports (3:35) a. Clinical Community Oncology Program (Jagadeesh Ramdas) (3:35) b. Nursing Discipline (Kathy Kelly) (3:40) c. Integrative Medicine Sub-committee (Catriona Mowbray) and Nutrition Subcommittee (Elena Ladas) (3:45) d. Patient Reported Outcomes Center (David Freyer) (3:50) e. Adolescent and Young Adult Sub-committee (David Freyer) (3:55)

Joint CCL/HSCT Open Session Wednesday, October 9, 2013 4:00 p.m. – 5:00 p.m. 1. ACCL1034 (4:00) Impact of Chlorhexidine on Reducing Bloodstream Infection (Danielle Zerr) 2. ACCL0934 (4:10) RCT of Levofloxacin to Prevent Bacterial Infection (Sarah Alexander) 3. ACCL1131 (4:20) Open-label Trial of Caspofungin to Prevent Fungal Infection in SCT (Christopher Dvorak) 4. ACCL1031 (4:30) Randomized Trial of Caphosol to Prevent Mucositis (Nat Treister) 5. ACCL1231 (4:40)

Randomized, Placebo-controlled Study of Olanzapine for the Control of Chemotherapyinduced Nausea in Children receiving Highly Emetogenic Chemotherapy as Hematopoietic Stem Cell Transplant Conditioning (Lee Dupuis)

Apixaban PI Meeting (Sarah O’Brien) Wednesday, October 9, 2013 5:00 p.m. – 7:00 p.m.

2013 Fall Group Meeting – Dallas, TX CRA Education Wed Chair- Sally Muehle Wednesday, 9/9/2013 7 a.m. – 8 a.m. 8 a.m. – noon 2 p.m. – 4 p.m. 5 p.m. – 6 p.m. AGENDA 1. 7 a.m. – 8 a.m. Orientation for CRAs new to the meeting. Barb Shepperd a. Tips for session attendance b. Inclusion of some tips for CRA committee involvement 2. 8 a.m. – noon

SoCRA Exam

3. 2 p.m. – 4 p.m. CRA Education a. Practical Aspects of Specimen Submission Yvonne Moyer/ Lisa Beaverson b. Practical Aspects for RAVE Steven Jong/Smita Subramanian c. Intro to MiniNetworks Stephanie Badour 4. 5 p.m. – 6 p.m. Poster Presentations – Dawn Borgerson Title: Adobe PDF Printer Feature – A Time Saver When Utilizing Electronic Files Washington University Medical Center Authors: Sally Jones, MA, CCRP, Lisa Murray, MA, CCRP, Gina Filley BSN, CCRP, Tia Thomas, CCRP; Amy Schmidt, MSW; Brunilda Lluka; Robert J. Hayashi, MD Title: COG Recertification Audit: Are you Ready? Tools to Remain Audit Ready Kaiser Permanente Northern California, Division of Research Authors: Susan Ledesma; Susan Leu Title: Development of a Standard Order set to Expedite the Ordering Process of Antibiotics for Patients Presenting with Fever and Neutropenia in the Outpatient Setting Monroe Carell Jr. Children’s Hospital at Vanderbilt Authors: Julie Isbell, MSN, RN, CPON, Laura Hall, PharmD, Katie Bruce, PharmD, Candy Stefansic, MSN, RN, CPON, Allison Duffey, BSN, RN, CPON, Anthony Owen, BSN, RN, CPN,Cecilia DiPentima, MD, Scott Borinstein, MD, Debra Friedman, MD, Christy Osgood, MD

Title: Documenting Consent Discussion: A Compliance Tool for Providers Dana-Farber/Boston Children’s Cancer and Blood Disorders Center Authors: Ahmed Faisal, BA; Lindsay Williams, BA; Allie Steinberger, BA; Ian Dumont, BA; Sarah Hunt, MPH Title: Electronic Medical Records: Not a Replacement but a Catalyst to Improve Communication among Clinical and Research Staff. Mount Sinai Medical Center, New York City Authors: Birte Wistinghausen, MD, Venesha White, CCRP Title: From Once Upon a Time to Happily Audit After: Retelling the Story through Accurate Documentation Cincinnati Children’s Hospital Medical Center Authors: Lori Backus, Sarah Casello, Jan Englehart, Jenny Thomas-Quinn Title: How CRA Involvement Can Streamline Enrollment in Cancer Registry Studies Children’s Hospitals and Clinics of Minnesota Authors: Brown, Anastasia B.A, Haltvick, Maggie, B.S. Title: Improving Clinical Trial Efficiency by Managing Workload with RETA, the University of Michigan’s Research Effort Tracking Application The University of Michigan C. S. Mott Hospital; Comprehensive Cancer Center Clinical Trials Office Authors: Kevin Frank, MS, CCRP; Kate Ernsting, MA, CCRP; Lora Girata, MPH; Monica Orians, MT (ASCP), CCRC; Beesea Hsieh, MS; Matt Innes, BSE, MBA; Rajen Mody, MD Title: Increasing Communication and Compliance with IND Studies in Pediatric Oncology Washington University Medical Center Authors: Gina Filley BSN,CCRP, Jennifer Wofford RN MSN APRN PNP-BC CPON, Kari Winchester BSN, Lisa Murray, MA, CCRP; Sally Jones, MA, CCRP; Tia Thomas, CCRP; Amy Schmidt, MSW; Bruna Lluka; Robert J. Hayashi, MD Title: Need for a custom-designed electronic form to document the informed consent process. Children's Hospital at Albany Medical Center Authors: Kelly Clickner RN, CCRA, Kevin Feisthamel MS, Vikramjit Kanwar MBA, MRCP(UK) Title: Quality Monitoring at the Biopathology Center Biopathology Center at Nationwide Children’s Hospital Authors: Lisa Beaverson, BA, CCRP, Lauren Noyes, MHA, Eben Infante, BA Title: Standard Start Time Pilot for Pediatric Chemotherapy in an Inpatient Setting Monroe Carell Jr. Children’s Hospital at Vanderbilt Authors: Sarah Castelo, PharmD, Virginia Spickler, RN MSN CPON CPNP, Daniel Favre, PharmD Title: The CRA Fun Fact: An Efficient Way to Disseminate Information Washington University School of Medicine

Authors: Lisa Murray, MA, CCRP; Sally Jones, MA, CCRP; Gina Filley, BSN, CCRP; Tia Thomas, CCRP; Amy Schmidt, MSW; Brunilda Lluka; Robert J. Hayashi, MD Title: The Eligibility Checklist: A Tool to Verify and Document Inclusion and Exclusion Criteria All Children's Hospital Johns Hopkins Medicine Authors: Jennifer Flanary, RN, BSN, CCRP, Frances Hamblin, RN, BSN, CPHON, CCRP; Ashley Repp, BSN, CPHON; Carolyn Bell, RN, MS, CCRP, CPON and Michael Gates, RN Title: The Informed Consent Process: A Tool to Improve Documentation University of Texas Health Science Center at San Antonio Authors: Virginia Diaz, MBA, Anne-Marie Langevin, MD, Julie Garcia, MSN, Frances Maldonado Title: Tools for Tracking Investigational Drugs Driscoll Children’s Hospital Authors: Roel Basaldua, PharmD; Thomas Hurd, BS; Cris Hogue, PharmD Title: Tools to improve documentation and compliance with family administration of antineoplastic agents. University of Texas Southwestern Medical Center Dallas Authors: Sarmistha Sen, M.S.; Tanya Carens Watt, M.D. Title: Use of Calendars to Improve Documentation of Adherence to Oral Chemotherapy Mission Children’s Hospital Authors: Anne Bowers, RN BSN, Dianne Lancaster, RN BSN, Melanie Clark, RN BSN. Title: Using a standardized Clinical Research Tool Kit to enhance data collection and ensure protocol compliance at Texas Children’s Cancer Center (TCCC) . Texas Children’s Hospital/Baylor College of Medicine Authors: Mrinalini Bilgi, Susan Burlingame, Natosha Evans, Manju George, Marissa Gonzalez, Sigmund Haidacher, Jim Jacob, Lucy Leeper, Brittany Pena-Alvarado, Josalind Randall Title: Validation of New Patient Enrollment Checklist to Ensure Quality of Clinical Trial Research at Ann & Robert H. Lurie Children’s Hospital Ann & Robert H. Lurie Children’s Hospital Authors: Jill Woodman, CCRP, Margaret Nevins, CCRP, Monica Newmark, RN, Yolanda Santiago, CCRP, Katie Sparks, David Walterhouse, MD

2013 Fall Group Meeting – Dallas, TX RARE TUMORS Chair – Carlos Rodriguez-Galindo Vice-Chair – Gail Tomlinson

WEDNESDAY 7:00 am – 8:00 am Rare Tumors Steering Committee a. Review agenda b. Committee updates c. Grant and funding updates

08:00 am – 10:00 am BREAKOUT SESSIONS

Meyers 1. Liver Tumors Subcommittee a. AHEP0731 Katzenstein i. Study status ii. High-risk proposal and amendment iii. Intermediate-risk Bridge study iv. PRETEXT central review b. CHIC Meyers/Krailo/Lopez-Terrada i. CHIC-1 – HB-IRG (Hepatoblastoma International Risk Groups) ii. CHIC-2 – Prognostic factors response to therapy iii. CHIC-3 – Prognostic significance pathologic subtypes (Ranganathan/Lopez-Terrada) iv. CHIC-4 – Consortium Grant Rare tumors Liver Pancreas v. Liver Tumor Consult Service O’Neill c. Pathology – Liver Tumor International Consensus Classification Lopez-Terrada d. Phase 2 Studies Trobaugh-Lotrario e. Pediatric Hepatoblastoma International Therapeutic Trial (PHITT) Tiao f. Publications i. Review of projects and manuscript status ii. Statistical support – Funding – Prioritization 2. Germ Cell Tumor Subcommittee a. AGCT0132

Frazier

b. c.

d.

e.

i. Low risk ovarian Billmire ii. Low risk testicular Rescorla iii. Role of consolidation Shaikh iv. Outcome of Int Risk Patients Shaikh AGCT0521 Rodriguez-Galindo MaGIC Initiative i. Overview of projects Frazier ii. New risk stratification Frazier iii. JEB vs. PEB Frazier iv. Immature teratoma Pashankar v. New COG protocol: Stromal Cell Tumors Brown/Schultz GCT1231: Design Frazier/Krailo i. New Poor Risk Trial: Design & Politics Frazier ii. New: Relapsed Trial for GCT Laetsch/Amatruda Publications i. Review of projects and manuscript status ii. Statistical support – Funding – Prioritization

Pashankar 3. Infrequent tumors Subcommittee a. ACC initiatives i. ARAR0332 Rodriguez-Galindo b. NPC initiatives i. ARAR0331 Rodriguez-Galindo ii. New pilot study Louis/Pashankar iii. NPC epidemiology Shurer/Spector c. Other initiatives Pashankar d. Publications i. Review of projects and manuscript status ii. Statistical support – Funding – Prioritization 4. Retinoblastoma Subcommittee Chintagumpala a. Protocol updates i. ARET 0332 Chintagumpala ii. ARET 0321 Dunkel iii. ARET 0231 Jubran b. New concepts i. ARET12P1 Chintagumpala/Gombos ii. Intraocular chemotherapy Kim/Brennan iii. Metastatic retinoblastoma Dunkel c. Publications i. Review of projects and manuscript status ii. Statistical support – Funding – Prioritization

GENERAL SESSION

10:00 am – 12:00 pm Meyers Frazier

1. Liver Tumors 2. Germ Cell Tumors 2:00 pm – 4:00 pm 3. Infrequent tumors 4. Retinoblastoma

Pashankar Chintagumpala

4:00 pm – 6:00 pm 5. Biology Studies a. Germ cell tumors b. Retinoblastoma c. Hepatoblastoma d. Adrenocortical carcinoma e. Nasopharyngeal carcinoma f. Rare tumors biology protocol

Amatruda/Tomlinson Amatruda Brennan Tomlinson Malkin Kamihara Amatruda

THURSDAY 8:00 am – 12:00 pm 2:00 pm – 6 pm Pediatric Hepatoblastoma International Treatment Trial (PHITT) planning meeting

2013 Fall Group Meeting – Dallas, TX

NURSING NEW MEMBER ORIENTATION / FIRST TIME ATTENDEES Leader: Katy Murphy and Jenn Wofford Nursing Discipline Member-At-Large Representatives

Wednesday, October 9 2013 7:00 a.m. – 8:00 a.m.

AGENDA

7:00 - 7:10

Welcome & Introductions – Katy Murphy, Jenn Wofford & Wendy Landier

7:10 - 7:25

Overview of COG Meeting Structure – Jenn

7:25 – 7:35

Nursing Sessions at COG – Katy • Patient-Family & Professional Education in COG • EBP/Clinical Trial Interactive Session • Plenary-CEU session • Disease and Protocol Committee Nurses • Research/Scholars

7:35 – 7:50

How to Become More Involved in COG – Wendy & Jenn

7:50 – 8:00

Questions & Discussion – Jenn & Katy

OPEN MEETING – All nurses and patient advocates welcome to attend

2013 Fall Group Meeting – Dallas, TX NEUROBLASTOMA DISEASE COMMITTEE Chair: Julie R. Park Wednesday October 9, 2013 7:00 AM – 9:00 AM

Time 7:00-7:10

AGENDA General Session – Open Studies Topic Introduction • Meeting plans • Review of scientific goals and timelines • Updates on major accomplishments

7:10 – 7:25

International Task Force

7:25– 7:40

OMA Task Force

7:40– 7:55

ANBL09P1

7:55 – 8:05

ANB12P1 • Amendment • New Correlative Aims

8:05 – 8:20

ANBL0032 • Amendment

8:20 – 8:35

A3973 and ANBL0032 MRD testing

8:35 – 8:45

ANBL1221

8:45 – 8:55

Discussion/Wrap-Up

Discussant Park/Bagatell

Parikh/Matthay Marachelian Weiss Granger

Yu

Seeger Mody Park/Bagatell

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 7:40 Estimated End Time: 8:45 a. ANBL09P1 – MIBG therapy; presenter: Weiss b. ANBL0032 – ch14.18; presenter: Yu c. ANBL1221 –ch14.18, temsirolimus; presenter: Mody

2013 Fall Group Meeting – Dallas, TX Canadian Regulatory Affairs Chair - Jacqueline Halton, MD Wednesday, October 9, 2013 7:00 a.m. – 9:00 a.m. AGENDA

1. Overview of SMO Office 2. Submission Statistics 3. COG Issues 4. Drug Updates/Issues 5. Safety Reporting 6. Audits/Monitoring a. COG b. SMO Office 7. Communities of Practice a. Pharmacy b. CRA c. Nurse Practitioners 8. Histiocyte Society LCH-IV PI Meeting

2013 Fall Group Meeting – Dallas, TX Myeloid Disease Steering Committee Chair- E. Anders Kolb, M.D. Wednesday, October 9, 2013 7:00 a.m. – 9:00 a.m. AGENDA 1. 7:00 to 7:10 - Call to Order, general updates – Andy Kolb 2. 7:10 to 7:30 - Funding Overview – Andy Kolb a. BISQFP Strategy – Soheil Mechinchi, Andy Kolb b. Program Project Strategy – Richard Aplenc 3. 7:30 to 7:45 - AAML1031 Updates – Richard Aplenc 4. 7:45 to 8:00 – AAML1331 Updates – Matthew Kutny a. Plan for BIQSFP submissions b. Timeline 5. 8:00 to 8:15 – AAML1231 Updates – Jason Berman a. Plan for BIQSFP submissions b. Timeline 6. 8:15 to 8:30 – AAML05P1 Updates – Shalini Shenoy a. Accrual projections b. DSMC, Peds CIRB follow up. 7. 8:30 to 8:45 – New Agent Updates – Todd Cooper 8. 8:45 to 8:55 – Phase 3 Working Group – Andy Kolb

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 7:00am Estimated End Time: 9:00am Meeting is closed to Industry

2013 Fall Group Meeting – Dallas, TX NON HODGKINS LYMPHOMA- Working Group Session I Active/Pending Protocols Chair- Catherine Bollard Wednesday 10/9/13 7:30 a.m. – 12:00 p.m. AGENDA Agenda item 1 7:30a.m. -7:45a.m. – Welcome/Introduction Presenter: Catherine Bollard Agenda item 2 7:45a.m. – 8:15a.m. - B-NHL Protocol ANHL1131 Presenter: Tom Gross Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:15 Estimated End Time: 8:45 Agenda item 3 ALCL Protocol ANHL12P1 Presenter: Eric Lowe Agenda item 4 8:45a.m. - 9:30a.m. - NHL Biology Working Group reports Presenters: Megan Lim and Bruce Shiramizu Break 9:30a.m. - 9:45a.m. Agenda item 5 9:45-9:50 ALTE11C1study - assessment of surrogate markers of ovarian reserve in adolescents with lymphoma. Presenter: Jennifer Levine Agenda item 6 9:45a.m.-10:00a.m. - ANHL04B1 – the rare NHL registry Presenter: Amanda Termuhlen Agenda item 7 10:00a.m. - 10:45a.m. - Lymphoblastic lymphoma Task Forces reports AALL07P1, AAL0434, AAL0932 and correlative studies Presenters: Rob Hayashi, Amanda Termuhlen, Birte Wistinghausen, Michelle Hermiston

Agenda item 8 10:45-11:15 – PTLD Presenters: Cath Bollard and Birte Wistinghausen Agenda item 9 11:15-11:45 – LCH Presenter: Carl Allen Agenda item 10 11:45-12:00 - Discussion

2013 Fall Group Meeting – Dallas, TX ALL COMMITTEE Stephen Hunger, Mignon Loh, Elizabeth Raetz, James Whitlock Wednesday, October 9th, 2013 8:00 a.m. – 12:00 p.m. AGENDA

1. Introduction and overview – Stephen Hunger (30 min) 2. AALL0932 (Standard Risk Precursor B-ALL) – Anne Angiolillo (10 min) 3. Results from AALL0331 (Standard Risk Precursor B-ALL) – Kelly Maloney (10 min)

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:50 AM Estimated End Time: 9:00AM 4. AALL0434 (T-ALL) – Kim Dunsmore and Stuart Winter

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 9:00 AM Estimated End Time: 9:15 AM 5. AALL1231 (T-ALL successor) – David Teachey

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 9:15 AM Estimated End Time: 9:30 AM 6. AALL0631 (Infants) – Joanne Hilden and Patrick Brown

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 9:30 AM Estimated End Time: 10:00 AM 7. AALL1131 (High Risk Precursor-B ALL) – Michael Burke and Wanda Salzer

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 10:00 AM Estimated End Time: 10:15 AM 8. AALL07P1 – Terzah Horton

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 10:15 AM Estimated End Time: 10:30 AM 9. AALL1331 (New Relapsed ALL Trial) – Patrick Brown

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 10:30 AM Estimated End Time: 10:45 AM 10. Update on Cancer Control studies for ALL patients a. RCT of Apixaban for Thromboembolism Prevention during ALL Induction Chemotherapy – Vilmarie Rodriguez b. ACCL0934: RCT of Levofloxacin to Prevent Bacteremia -- Sarah Alexander c. ACCL1034: Chlorhexidine wipes to reduce CLABSI - Danielle Zerr

11. ALL Biology Updates – Mignon Loh (15 min) 12. Outcome For Children With Hypodiploid ALL—Meenakshi Devidas (SIOP 2013; 15 min) 13. MRD assessment eliminates the need for day 8/15 marrow examination—Michael Borowitz (ASCO 2013; 15 min) 14. Osteonecrosis risk in the AALL0331 standard risk ALL trial—Leonard Mattano (ASCO 2013; 15 min) 15. AALL02P2: Treatment of ALL with first isolated testicular relapse with limited use of irradiation—Julio Barredo (SIOP 2013; 15 min)

2013 Fall Group Meeting – Dallas, TX ANUR1131 Evaluator Training (Invitation Only) Co-Chairs- Joan Haase & Sheri Robb Wednesday, October 9, 2013 8:00 a.m. – 5:00 p.m. AGENDA Time

Activity

Presenter

Content outline

8:00 - 8:15

Welcome & Training Overview

Robb/Haase

Orientation to Training Schedule, Team Introductions, Training Evaluation Form

8:15 - 8:45

Brief Study Overview

Robb/Haase

Study Background, Design Schema, Aims

8:45 - 9:00

Position Description & Position- Specific Workflow

Robb

Overview of organizational charts & directory. Review general policies procedures, & timelines. Collect signed position descriptions.

9:00 - 9:30

Theories of the Problem and Intervention

Haase/Robb

Discussion of ways theory informed intervention design/delivery.

9:30 - 9:50

AYA Development & Cancer Treatment

Haase/Robb

Overview of AYA development, cancer treatment, side effects, & coping.

9:50 - 10:00

Break

10:00 - 11:00 Introduction to SMART II eRde Database & Oncourse Websites

Robb

View database and provide overview of use and role-specific functions.

11:30 - 12:30 Lunch (On Your Own)

Haase/Robb

Review Session Procedures & Role Play.

12:30 - 3:00

Evaluation Protocol Training

Robb/Haase

Review Session Procedures & Role Play.

3:00 - 3:15

Break

3:15 - 4:30

Quality Assurance Procedures

Haase/Robb

Role Specific QA Strategies & Procedures; Revisit the SMART II eRde database - QA checklist entries.

4:30 - 5:00

Training Evaluations & Wrap-Up

Robb/Haase

Distribute & Collect Evaluations.

2013 Fall Group Meeting – Dallas, TX SURVIVORSHIP AND OUTCOMES COMMITTEE Chair –Saro Armenian Wednesday, October 9, 2013 9:00 a.m. – 11:00 a.m. AGENDA Introduction: Survivorship and Outcomes (Armenian) Active studies ALTE11C1 (Levine) - Longitudinal Assessment of Ovarian Reserve in Post Menarchal Adolescents Undergoing Gonadotoxic Treatment for Childhood Cancers ALTE11C2 (Chow) - Dexrazoxane Follow-up Study – Revisiting POG 9404/9425/9426 AALL03N1 (Bhatia) - Understanding the Ethnic and Racial Differences in Survival in Children with A.L.L. ALTE03N1 (Bhatia) - Key Adverse Events after Childhood Cancer ALTE05N1 (Bhatia) - Umbrella Long-term Follow-up Protocol

Studies in Development ALTE12C1 (Shnorhavorian) -Testicular Effects in Osteosarcoma Survivors Treated with Modern Chemotherapy ALTE1331 (Armenian) -

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Congestive Heart Failure: A Phase IIB Randomized Placebo-Controlled Trial

ANBL13D1 (Landier):

Genetic Predisposition to Platinum-Induced Hearing Loss in High-Risk Neuroblastoma

Physical activity intervention in children with ALL (Ness)

2013 Fall Group Meeting – Dallas, TX ________________________________________________________________________ CCL: NEUROTOXICITY (Open) Chair – Nicole Ullrich, MD, PhD CoChair – Kristina Hardy, PhD

Wednesday, October 9 9:00 a.m. – 12:00 p.m. AGENDA

1. Introductions Nicole Ullrich / Kristi Hardy

2. Current projects for neurotoxicity a. Modafinil b. High Risk ALL c. Completing neuropathy d. Completing ototoxicity 3. Proposals a. Ototoxicity b. Prevention of cognitive decline in brain tumor patients treated with radiation 4. Future directions a. Regular conference calls b. Process for concept generation/moving forward c. Harmonization of assessments for cognitive interventions d. Interaction with other disease committees

2013 Fall Group Meeting – Dallas, TX Cancer Control & Supportive Care Antiemetic Breakout Chair- Lee Dupuis Wednesday, October 9, 2012 9:00 a.m. – 10:30 a.m. Location: Cumberland I AGENDA 1.

PeNAT translation projects:

9:00 to 9:20

a. Spanish - Erica Garcia, Christus Santa Rosa b. French - Lee Dupuis, The Hospital for Sick Children 2.

CINV QI Initiatives: a. Andrea Orsey, Connecticut Children’s’ Hospital b. Melissa Beauchemin, Columbia University Medical Centre

9:25 to 9:45

3.

Electronic platforms for nausea severity assessment: Tina Baggott

9:50 to 10:05

4.

Olanzapine concept: Lee Dupuis

10:05 to 10:15

5.

Discussion, new ideas

10:15 to 10:30

2013 Fall Group Meeting – Dallas, TX

NEUROBLASTOMA DISEASE COMMITTEE Session Chairs: Michael Hogarty and John Maris Wednesday October 9, 2013 9:00 AM – 12:00 PM AGENDA Biology Time 9:00 – 9:20

Topic Relapse NBL Overview

9:20 – 9:35

Molecular Characteristics Relapse NBL • TARGET • Update on newer genomic resources and preliminary data

9:35 – 9:45 9:45 – 10:00

TARGET: Next steps (Discussion) Molecular Characteristics of Relapse NBL • RNASeq tools and review data Start of the Art: Future Directions for Precision Medicine

10:00 – 10:20

Discussant Hogarty Maris

Maris Asgharzadeh Katie Janeway

10:20 – 10:35 10:35 – 10:45

Break SU2C

10:45 – 11:05

Immunotherapy – Antibody

Sondel

11:05 – 11:20 11:20 – 11:40

Immunotherapy Immunotherapy - CAR

Seeger Jensen

11:40 – 12:00

Discussion

Maris

Hogarty and Maris

2013 Fall Group Meeting – Dallas, TX Myeloid Disease Committee General Session - Morning Chair- E. Anders Kolb, M.D. Wednesday, October 9, 2013 9:00 a.m. – 12:00 p.m. AGENDA

1. 9:00 to 9:20 - Call to Order, General Overview – Andy Kolb 2. 9:20 to 10:20 – AAML0531 Results – Alan Gamis 3. 10:20 to 11:00 – AAML0431 Updates – Jeffrey Taub 4. 11:00 to 11:45 – AAML1231 Updates – Hans Hitzler, Jason Berman a. Questions and Challenges in DS AML b. AAML1231 Study Design 5. 11:45 to 12:00 – Young Investigators – John Horan

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 0900 Estimated End Time: 10:30 AAML0531 Updates and Discussion

2013 Fall Group Meeting – Dallas, TX Hodgkin Disease Retrieval Subcommittee Chair- Peter Cole, MD Wednesday, October 9, 2013 10:00 a.m. – 11:00 a.m. AGENDA

1. AHOD1221 Phase I/II trial of Gemcitabine with Brentuximab Vedotin -- Protocol update – Peter Cole, MD 2. Development of subsequent retrieval protocols – Richard Drachtman, MD and Paul Harker-Murray MD a. Stratification schema for patients with relapsed or refractory HL

b. Identification of novel agents to be studied c. Strategies to integrate novel agents within our retrieval schema

2013 Fall Group Meeting – Dallas, TX Hodgkin Disease Biology Subcommittee Chair- Terzah Horton, MD/PhD Wednesday, October 9, 2013 11:00 a.m. – noon AGENDA

1. Hodgkin Lymphoma Molecular Classifier-Protocol Update Terzah Horton a. AHOD12B2 update b. Embedded biology for AHOD1331 (high risk HL) c. Embedded biology for Alliance protocol AHOD1431 (low-risk HL)

2. Hodgkin Lymphoma Pharmacogenetic Analysis Project Update

John Perentesis

3. St. Jude’s Pharmacogenomic analysis

Jun Yang

4. Telomere Length in HL project

Donna Wall

2013 Fall Group Meeting – Dallas, TX Return of Research Results Committee Chairs- Kathy Ruccione/Conrad Fernandez Wed 10.9.2013 10:30am -12:00pm

AGENDA

1. Introductions (Kathy Ruccione/ Conrad Fernandez) 10 minutes 2. Brief history of return of results task force and committee creation (Conrad Fernandez) 5 minutes 3. Review of current status of website (Conrad Fernandez) 5 minutes 4. Review of the process for getting a summary on the web (Kathy Ruccione) 10-15 min 5. Discussion of tasks expected of the committee (Kathy Ruccione/ Conrad Fernandez) 10-15 min 6. Discussion of meeting plans going forward (Kathy Ruccione/ Conrad Fernandez) 10 min 7. Committee correspondence (Conrad Fernandez/ Kathy Ruccione) 10-15 min 8. Other (Conrad Fernandez/ Kathy Ruccione) (15 min) No discussion of investigational drugs planned.

2013 Fall Group Meeting – Dallas, TX Supportive Care Guideline Working Group Chair- Lee Dupuis Wednesday, October 9, 2012 10:30 a.m. – 12:00 p.m. Location: Cumberland I AGENDA 1. Standard format for COG supportive care guidelines 2. Discussion of AGREE II assessment of FN guidelines 3. Selection of possible external COG reviewers (5-8) 4. Plans & Timelines for rolling out endorsed guidelines i. How to phase in endorsed guidelines and phase out current supportive care guideline ii. Communication plan iii. Timeline for FN endorsed guideline iv. Selection of 2nd guideline topic for endorsement & timelines

2013 Fall Group Meeting – Dallas, TX Down Syndrome (DS) Task Force Chair- Kelly Maloney Wednesday, October 9, 2013 2:00 PM- 4:00 PM AGENDA

1. Update on AALL0932 DS enrollment – Hans Hitzler a. Number of enrollments b. Toxicities

2. Update on AALL1131DS enrollment – Karen Rabin, Vilmarie Rodriguez a. Number of enrollments b. Toxicities

3. Additional issues/discussion – Kelly Maloney

2013 Fall Group Meeting – Dallas, TX AALL1231: T-ALL Trial Development David Teachey and Elizabeth Raetz Wednesday, October 9th, 2013 2:00 p.m. – 4:00 p.m. AGENDA

1. Introduction and overview - David Teachey (5 min) Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:05 PM Estimated End Time: 2:25 PM 2. AALL1231 Trial Design, Overall Objectives, and Timeline - David Teachey (20 min) 3. Dexamethasone, Bortezomib, and ON - Maria Luisa Sulis (10 min) 4. MRD: Planned risk stratification and Next Gen Sequencing - Brent Wood (15 min) 5. Correlative Studies (25 min) a. b. c. d.

Mechanisms of Bortezomib Response and Resistance – Terzah Horton Significance of Biochemical Phenotype in ETP ALL - Michelle Hermiston Notch signaling, the proteasome, and ETP – Patrick Zweidler-Mckay Internet based physical activity intervention with an accelerometer – Kiri Ness

6. Considerations for refractory patients –Mike Pulsipher and David Teachey (15 min) 7. Wrap-up and Discussion (30 min)

2013 Fall Group Meeting – Dallas, TX Relapsed T-ALL Trial Development Jim Whitlock, Michelle Hermiston, David Teachey, Stuart Winter Wednesday, October 9, 2013 2:00 p.m. – 4:00 p.m. AGENDA

1. Overview of opportunities and challenges – Jim Whitlock (10 min)

2. Potential study designs – Michelle Hermiston (50 min) a. Reinduction options b. Post-induction therapy options c. Stem cell transplantation options

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 3:00 p.m. Estimated End Time: 3:20 p.m. 3. New agent possibilities – David Teachey (20 min)

4. Biologic correlatives – Stuart Winter, Michelle Hermiston (40 min)

2013 Fall Group Meeting – Dallas, TX Nursing Education/Clinical Trials Joint Symposium: “Patient-Family and Professional Education in the Children’s Oncology Group” Co-Chairs- Joy Bartholomew and Marcia Leonard (Clinical Trials) Maureen Haugen (Nursing Education) Katy Murphy (Patient-Family Education) Wendy Landier (Nursing Discipline Chair)

Wednesday, October 9, 2013 2:00 pm – 4:00 pm

AGENDA

1. Introduction, session goals 2. Overview of patient-family education within COG 3. COG nursing initiatives for patient/family education 4. Overview of professional nursing education within COG 5. COG initiatives for professional nursing education 6. Conclusions, future directions

OPEN MEETING ---- All are invited to attend and participate

2013 Fall Group Meeting – Dallas, TX Combined Sarcoma Biology Session Chairs- Stephen Lessnick and Steve Skapek Wednesday, October 9, 2013 2:00 p.m. – 5:00 p.m. AGENDA Laboratory/Clinic intersection 1) 2) 3) 4)

Actionable mutation testing – K. Janeway Myogenic differentiation and mTOR inhibition – S. Skapek Targeting EWS-FLI1- J. Toretsky (25 minute, 5 minute questions) Discussion

2:00 – 2:15 pm 2:15 – 2:30 pm 2:30 – 2:55 pm 2:55 – 3:05 pm

Biomarker Studies 1) 2) 3) 4) 5)

Gene expression profiling in ES – B. Lawlor Microsatellite markers, p53 and p16Ink4a in ES – S. Lessnick Proteomic biomarkers in OS – C. Man DNA methylation in RMS – S. Diede Discussion

3:05 – 3:20 pm 3:20 – 3:35 pm 3:35 – 3:50 pm 3:50 – 4:05 pm 4:05 – 4:15 pm

Cancer Susceptibility 1) 2) 3)

Genetic predisposition to RMS – P. Lupo Genetic basis for anaplastic RMS – D. Malkin Discussion

4:15 – 4:30 pm 4:30 – 4:45 pm 4:45 – 5:00 pm

2013 Fall Group Meeting – Dallas, TX HODGKIN LYMPHOMA INITIAL THERAPEUTICS Chair: Frank G. Keller Wednesday, October 9, 2013 2:00 PM-6:00 PM AGENDA 1. 2:00-2:10:

Introduction

Frank Keller

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:10 Estimated End Time: 3:10 2. 2:10- 2:40: AHOD1331: High risk classical HL Sharon Castellino 3. 2:40-3:10:

AHOD1431: Low risk classical HL

4. 3:10-3:40

Radiation Therapy considerations: David Hodgson Involved Site RT and Normal Tissue Dosimetry

5. 3:40-4:10

Lymphocyte Predominance Proposal

6. 4:10-6:00:

Secondary Objectives

a. 4:10-4:40

Imaging

b. 4:40-5:05

Cost Effectiveness

c. 5:05-5:35

Other non-relapse events a. Neurocognition b. ALTE11C1: Ovarian c. ALTE11C2: HEART

d. 5:35-6:00

Biology

Shana Jacobs

Joel Kaplan

Steve Cho, Stephan Voss Tara Henderson

Casey Hooke/Sunita Patel Jennifer Levine Eric Chow Terzah Horton

2013 Fall Group Meeting – Dallas, TX

NEUROBLASTOMA DISEASE COMMITTEE-3 Chair: Julie R. Park Wednesday October 9, 2013 2:00 PM – 6:00 PM AGENDA DVL and Proposed Clinical Trials Time 2:00 – 2:10

Overview

2:10 – 2:30

Neuroblastoma Eligibility in the INRG era

2:30 – 2:45

ANBL1232

Meany

2:45 – 3:00 3:00 – 3:15 3:15 – 3:45

Attiyeh

4:15 – 4:30 4:30 – 4:50 4:50 – 5:00

Biologic Classification/Validation update Break Building on Biology: DVL Update – Discussion to complement focus topics of Biology Session , include pharma and COG Building on Biology: NANT update – Discussion to complement focus topics of Biology Session Break High Risk Induction/Consolidation Discussion

5:00 – 5:20

Maintenance Task Force

5:20 – 5:30 5:30 – 5:45

Discussion Wrap-Up

3:45 – 4:15

Topic

Discussant Park/Bagatell Bagatell/Meany

Mosse

Matthay or Marachelian?

Bagatell/Dubois

Glade-Bender/ Marachelian Park/Bagatell

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:45 Estimated End Time: 4:15 a. DVL – Presenter: Mosse b. NANT – Presenter: Marachelian

2013 Fall Group Meeting – Dallas, TX Myeloid Disease Committee General Session - Afternoon Chair- E. Anders Kolb, M.D. Wednesday, October 9, 2013 2:00 p.m. – 6:00 p.m. AGENDA

1. 2:00 to 2:45 – AAML1031 – Richard Aplenc 2. 2:45 to 3:15 – AML Supportive Care Review – Danielle Zerr, Sarah Alexander. 3. 3:15 to 3:30 – Cancer Control Studies Updates – Brian Fisher 4. 3:30 to 3:45 – AAML0631 – John Gregory 5. 3:45 to 4:10 – AAML1331 Planned Trial - Matthew Kutny 6. 4:10 to 4:40 – New Agents – Todd Cooper 7. 4:40 to 5:00 – AAML05P1 Updates – Shalini Shenoy JCML HSCT Trial - Shalini Shenoy 8. 5:00 to 5:20 – Cytogenetics – Betsy Hirsch 9. 5:20 to 5:40 – Biology Committee Update – Soheil Meshinchi 10. 5:40 to 6:00 – St. Baldrick’s Infrastructure Award Announcement – Bob Arceci

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:00pm Estimated End Time: 4:00pm AAML1031 Updates and Discussion AAML1331 Planned Trial

2013 Fall Group Meeting – Dallas, TX

RENAL TUMOR -Session #1 Chair- Jeffrey Dome Wednesday, October 9, 2013 2:00 PM – 6:00 PM AGENDA 1. Welcome and announcements- Jeff Dome (5 minutes) 2. Current protocol updates (60 minutes) a. AREN03B2- Biology and Classification- Elizabeth Mullen (20 minutes) b. AREN0321- High-risk renal tumors- Jeff Dome (10 minutes) c. AREN0532- Low-risk Wilms tumor- Conrad Fernandez (10 minutes) d. AREN0533- Higher-risk Wilms tumor- David Dix (10 minutes) e. AREN0534- Bilateral Wilms tumor-Peter Ehrlich (10 minutes) 3. Renal Tumor Biology (85 minutes) a. Project updates-Vicki Huff (15 minutes) b. TARGET Analysis- Elizabeth Perlman (45 minutes) c. 1q gain as a prognostic marker- Eric Gratias (15 minutes) d. DICER1 mutation in cystic nephroma- Mariana Cajaiba (10 minutes) 4. Discipline Updates (45 minutes) a. Radiology –Geetika Khanna (15 minutes) b. Radiation Oncology- John Kalapurakal (15 minutes) c. Surgery- Peter Ehrlich (15 minutes) 5. NWTS Late Effects Study- Eric Chow (10 minutes) 6. DVL Updates- (35 minutes) a. New agents for renal tumors- Jim Geller (25 minutes) b. Liposomal vincristine- Raj Venkatramani (10 minutes) Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 5:20 PM Estimated End Time: 6:00 PM

2013 Fall Group Meeting – Dallas, TX

COG LONG-TERM FOLLOW-UP GUIDELINES SURVIVORSHIP AND OUTCOMES COMMITTEE

Melissa Hudson, Wendy Landier Sandy Constine, Smita Bhatia Wednesday, October 9, 2013 4:00 p.m. – 6:00 p.m.

AGENDA

1.

COG LTFU Task Force Updates (Melissa Hudson) a. Recent manuscript concepts b. Updates regarding current activities c. Other activities

2.

COG LTFU Guidelines Version 4.0 Update (Wendy Landier)

3.

Screening Yield – Recent Analyses (Wendy Landier & Melissa Hudson)

4.

International Guidelines Harmonization Group Update (Melissa Hudson)

5.

Disease-Focused Screening - Manuscript Plans (Melissa Hudson)

2013 Fall Group Meeting – Dallas, TX BEHAVIORAL SCIENCE COMMITTEE--STEERING Chair- Robert Noll Wednesday, October 9, 2013 4:00 p.m. – 6:00 p.m. AGENDA

1. Future Directions Behavioral Science Committee – Robert Noll 2. ALTE07C1 Plans Moving Forward – Leanne Embry 3. Cogmed and Cogstate Plans – Kristi Hardy 4. ALL open and pending studies – Rob Annett 5. CNS open and pending studies – Stephen Sands 6. Return of Results Committee – Amanda Thompson and Andrea Patenaude

2013 Fall Group Meeting – Dallas, TX Bone Tumor Steering Committee Chair: Richard Gorlick Wednesday October 9, 2013 5:00 PM – 6:00 PM

AGENDA

1. Update on Bone Tumor Committee Activities - Gorlick

5:00-5:15 PM

2. Ideas for a potential trial for patients with newly diagnosed ESFT – Discussion

5:15-6:00 PM

2013 Fall Group Meeting – Dallas TX Rhabdoid Tumor Working Group Chair- Susan Chi Wednesday October 9, 2013 7:00 p.m. – 8:30 p.m.

AGENDA

1. COG AREN 0321 High Risk Renal update- James Geller 2. COG ACNS 0333- Alyssa Reddy 3. Head Start III- Girish Dhall 4. MLN 8237- Cindy Wetmore 5. Preclinical testing- Aru Narendran 6. Epigenetics- Charles Roberts 7. Annoucement: Rhabdoid Tumor meeting, December 12-14, 2013, Paris, France.

2013 Fall Group Meeting – Dallas, TX

CANCER CONTROL AND SUPPORTIVE CARE STEERING COMMITTEE Chair- Lillian Sung AGENDA

Guideline Education Session (Lee Dupuis, Paula Robinson) Thursday, October 10, 2013 8:00 a.m. – 10:00 a.m.

CCL RI Meeting (Lillian Sung) *Invitation only* Thursday, October 10, 2013 6:00 p.m. – 7:30 p.m.

2013 Fall Group Meeting – Dallas, TX CNS Committee Agenda Chair – Amar Gajjar, MD Thursday October 10th 2013 8.00 am – 10.00 am Chair’s Address – 8.00-8.05 Medulloblastoma 8.05 am – 9.00 am ACNS0331 – Jeff Michalski (8.05 -8.15) ACNS0332 – Jim Olson (8.15 – 8.30) ACNS1222 update – Nick Gottardo (8.30-8.45) Craig Castellino – “Mechanisms of PPM1D in medulloblastoma tumorigenesis and invasion" (8.45 -9.00) Infant Tumors 9.00 am – 10.00 am ACNS0333 – Alyssa Reddy (9.00-9.15) ACNS0334 – Claire Mazewski (9.15-9.30) ACNS1221 – Lucie Lafay-Cousin (9.30-9.45) ATRT – future clinical studies – Susan Chi (9.45 – 10.00)

10.00 AM – 12 Noon – ASPHO/COG Education Session CME credit (1.5 hrs.) Thursday October 10th 2013 1.00 pm – 6.00 pm High Grade Glioma 1.00 pm – 1.45 pm ACNS0822 – Maryam Fouladi (1.00 -1.15) ACNS0423 – Reggie Jakacki (1:15-1:25) ACNS1421 update – Matthias Karajannis (1.25–1.45) Discussion of Investigational Drugs: Closed to Industry Representatives ACNS0822 update – Maryam Fouladi ACNS1412 – Matthias Karajannis DIPG 1.45 pm – 2.30 pm ACNS0927 update – Jack Su (1.45-1.55) ADVL1217 – Sabine Mueller (1.55-2.05) DIPG HTS - Charles Keller – (2.05-2.20) DIPG concept – Johannes Wolf (2.20-2.30) Discussion of Investigational Drugs: Closed to Industry Representatives ACNS0927 update – Jack Su ADVL1217 – Sabine Mueller DIPG Concept – Johannes Wolf

Low Grade Glioma 2.30 pm – 3.15 pm Biology Study – Dan Bowers, Charles Eberhart (2.30-2.45) ACNS1022 – Lenalidomide – Kathy Warren (2.45-3.00) ACNS0221 – Conformal RT – Joel Cherlow (3.00-3.15) Discussion of Investigational Drugs: Closed to Industry Representatives ACNS1022 – Lenalidomide – Kathy Warren COFFEE BREAK 3.15 pm-3.30 pm CNS Late Effects 3.30 pm – 4.00 pm ALTE07C1 update Leanne Embry (3.30 -3.45) ACCL10P1 update Kristi Hardy/Nicky Ullrich (3.45 -3.50) ACCL0922 update Nicky Ullrich (3-50 - 4.00) Ependymoma 4.00 pm – 4.30 pm ACNS0831 update – Amy Smith (4.00 – 4.10) ACNS11B1 biology – Uri Tabori/Nick Foreman (4.10 – 4.20) Ependymoma Relapse Concept – Peter Manley – Cabazitaxel as potential relapse therapy (4.204.30) Germ Cell Tumor 4.30 pm – 5.00 pm ACNS1123 update – Dhall/Bartels/Fangusaro/Khatua (4.30-5.00) Novel Agents and Phase II 5.00 pm – 6.00 pm ACNS1021 – Sunitinib – Cynthia Wetmore (5.00- 5.15) ACNS0821 – CPT11/TMZ/±Avastin – Adam Levy (5.15 – 5.30) PBTC update – Maryam Fouladi or designee (5.30-6.00) Discussion of Investigational Drugs: Closed to Industry Representatives ACNS1021 – Sunitinib – Cynthia Wetmore ACNS0821 – CPT11/TMZ/±Avastin – Adam Levy PBTC – Multiple agents – Maryam Fouladi or designee

ADJOURN

2013 Fall Group Meeting – Dallas, TX CRA Education Chair- Sally Muehle Thursday, 9/10/2013 7 a.m. – 8 a.m. 8 a.m. – 10 a.m. 5 p.m – 7 p.m. 7 p.m – 10 p.m.

AGENDA

1. 7a.m. – 8 a.m. Mini Network sessions. Stephanie Badour a. Building a network 2. 8 am - 10 a.m. CRA Education a. ANHL12P1 – Dr Lowe b. ARST1321 – Dr. Weiss c. AAML1031- Dr Aplenec

3. 5p.m. – 7 p m. ANHL1131- Dr. Gross / COG / Bracket a. Appetizers b. FAQs

4. 7 p.m – 10 p.m. CRA Social gathering TBA

2013 Fall Group Meeting – Dallas, TX YI Sessions Chair- Patrick Zweidler-McKay Vice-Chair- Christopher Pierson Thursday, Oct 10th, 2013 8:00 a.m. – 10:00 a.m. AGENDA

1. 8-8:05 am: Welcome to COG 2. 8:05-8:30am: Speaker Andy Kolb – My experiences in COG, YI to PI to Chair. 3. 8:30-10am: YI Project Fair - Representatives from many committees will be available to discuss projects and opportunities to become involved.

Thursday, Oct, 2013 6:00 p.m. – 8:00 p.m. AGENDA

4. 6-6:30pm: Mentor-Mentee Meetings - A time and place for mentees to meet with mentors… 5. 6:30-7pm: Selected YI Abstract oral presentations – Three top YI abstracts will give 10 minutes talks… 5. 7-8pm: Poster & Networking session – YIs will be presenting their work at posters from across disciplines/diseases

2013 Fall Group Meeting – Dallas, TX LEUKEMIA PHYSICAL FUNCTIONING STUDY (LPFS): LONGITUDINAL ASSESSMENT OF PERIPHERAL NEUROPATHY AND MOTOR FUNCTION IN CHILDREN TREATED FOR AVERAGE RISK LYMPHOBLASTIC LEUKEMIA Chair- Nina Kadan-Lottick, MD, MSPH Thursday, October 10, 2013 7:00 a.m. – 8:00 a.m. AGENDA

1. Introduction to the Leukemia Physical Functioning Study (LPFS) – Nina Kadan-Lottick, MD, MSPH a. Review the purpose and goals of the study b. Overall update on the study c. Introduce the coordinating center staff

2. Physical Functioning and Neuropathy – Kirsten K. Ness, PT, PhD a. Neuropathy Evaluation Challenges b. Neuropathy Evaluation Solutions

3. Study Participation Update -- Moira Whitley, MS, Project Manager/Lead CRA a. Logistic Issues b. FAQ’s 4. Subject Retention – Marilyn Hockenberry, PhD, RN, PNP, BC, FAAN a. Reasons for loss to follow-up b. Strategies to retain patients on studies 5. Proposed Future Intervention Study -- Kirsten K. Ness, PT, PhD 6. Question and Answer Session – Nina Kadan-Lottick, MD, MSPH Kirsten K. Ness, PT, PhD Marilyn Hockenberry, PhD, RN, PNP, BC, FAAN Moira K. Whitley, MS, Project Manager/Lead CRA

2013 Fall Group Meeting – Dallas, TX

Heme/Onc Discipline (closed) Chair- Susan Cohn, MD Thursday, October 10, 2013 7:00 a.m. – 8:00 a.m. AGENDA

1. Review topics and speakers for Fall Education Meeting 2014 – Susan Cohn 2. New initiatives a. Innovative educational sessions at COG i. Meet the experts ii. Difficult case presentations iii. Clinical trial design models iv. How to publish review articles b. Better ways to get group input after Education Session. (We currently do have a survey (CME) and have scored very high previously) c. Discuss new mechanisms for funding institutions for clinical trial work 3. Updates on progress of collaborative Task Forces with the COG Voting Body a. Review “real-world protocol” task force – Sheri Spunt

2013 Fall Group Meeting – Dallas, TX CYTOGENETICS COMMITTEE Kathleen W. Rao, Committee Chair Thursday, October 10, 2013 7:00 a.m. – 8:00 p.m. AGENDA

1. Update on Laboratory Performance – Nyla Heerema a. New Approved Laboratories b. Number/Percent of Laboratories with performance issues c. Technical issues

2. Training New Reviewers – Andrew Carroll

3. COG Cytogenomic Array project update – Betsy Hirsch a. Report Format for Array data submission b. Is there a minimal list of loci to be reported? c. Next Steps?

4. Open Discussion -- All

2013 Fall Group Meeting – Dallas, TX EWING SARCOMA (including local control) Chair- Stephen Lessnick Thursday, October 10, 2013 7:00 a.m. – 10:00 a.m. AGENDA 1) Ewing sarcoma studies in development a) Recurrent EWS i) Overview – Andy Collier ii) Supportive preclinical work – Andy Kolb iii) Local Control – Lor Randall/Nadia Laack b) Upfront Metastatic AEWS1221 i) Overview—Steve DuBois ii) Local Control—Lor Randall/Nadia Laack iii) Biology/biomarkers—Andy Kolb/Steve Dubois

7:00-7:30 AM

7:30-8:00 AM

2) Ewing sarcoma studies that need to be in development 8:00-8:45 AM a) Localized EWS next study, early process i) Study design, agents, other issues—Rich Gorlick ii) Local control concepts and ideas—Lor Randall/Nadia Laack 3) DVL Studies-Julia Glade Bender

8:45-8:55 AM

4) PARPi developmental planning – Weigel/Hawkins

8:55-9:05 AM

5) Ewing sarcoma ongoing studies a) Localized: AEWS1031 i) Update –Pat Leavey ii) Amendment –Nadia Laack b) R2-Pulm: AEWS0331—Doug Hawkins

9:05-9:20 AM

9:20-9:25 AM

6) Biology study progress AEWS07B1—Steve Lessnick

9:25-9:35 AM

7) Manuscripts – major findings, status updates, etc. a) AEWS07P1 – Leo Mascarenhas b) Multivariate analysis for Ewing sarcoma – Neyssa Marina c) Local control in Ewing sarcoma – Steve Dubois d) Microsatellites, p53/p16 – Steve Lessnick

9:35-10:00 AM

2013 Fall Group Meeting – Dallas, TX Diagnostic Imaging Chair- Marilyn J. Siegel, MD October 10, 2013 7.00 a.m. – 10.00 a.m. AGENDA

AGENDA ITEMS

1. Introduction

Marilyn J. Siegel

2. Update on IROC – Imaging and Radiation Oncology Core: the reorganization of QARC with ACRIN and Ohio State’s Imaging Corelabs. T. J. FitzGerald (15 mins) 3. Report from QARC

Fran Laurie

(15 mins)

4. Reports from clinical committee heads on imaging protocols/ publications (60-75 mins) a. b. c. d. e. f. g.

Wilms Neuroblastoma Soft tissue / bone tumors Liver tumors Hodgkin disease ALL CNS

Geetika Khanna Meg Parisi/Barry Shulkin Beth McCarville/Simon Kao Alexander Towbin Stephan Voss Richard Rittenhouse Jeff Bennett

5. RECIST 1.1 and WHO guidelines

Marilyn J. Siegel

6. Membership criteria

Marilyn J. Siegel

7. Other

2013 Fall Group Meeting – Dallas, TX International Affairs Committee Chair- Y Ravindranath Thursday, Date October 10, 2013 8:00 a.m. – 9:00 a.m. AGENDA

1. Chair’s report- Y Ravindranath Funding status, membership in core committee 2. GALOP Report- Luis Castillo 3. Office of Global Health- NCI- Tom Gross, Deputy Director for Science 4. Comments fr0m COG chair/vice -chair 5. Open discussion.

2013 Fall Group Meeting – Dallas, TX RENAL TUMOR STEERING COMMITTEE Chair- Jeffrey Dome Thursday, October 10, 2013 8:00 AM – 10:00 AM AGENDA

1. Every Child Project- Jeff Dome (10 minutes) 2. Clinical Project and Manuscript Update- Jeff Dome (15 minutes) 3. Surgical Protocol Violation Data- Peter Ehrlich (15 minutes) 4. Future Protocol Development a. FH Study- Elizabeth Mullen (40 minutes) i. Review of background data ii. Progress toward developing next study b. High-Risk Study- Jim Geller (30 minutes) i. RCC concept ii. Potential concepts and strategies for AREN0321 successor

2013 Fall Group Meeting – Dallas, TX CCL Guideline Education Lee Dupuis & Paula Robinson Thursday, October 10, 2012 8:00 a.m. – 10:00 a.m.

AGENDA 1. What is a practice guideline? 2. Role of clinical practice guidelines (CPGs) in COG 3. CPG development science: a. AGREE II, GRADE b. de novo, adaptation, endorsement 4. COG supportive care guideline endorsement process

2013 Fall Group Meeting – Dallas, TX ALL BREAKOUT #4: AALL1331 (RELAPSE ALL) TRIAL DEVELOPMENT Chair- Pat Brown Thursday, October 10th, 2013 8:00 a.m. – 10:00 a.m. AGENDA

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:00 a.m. Estimated End Time: 9:00 a.m. 1. Overview of AALL1331 Protocol Development – Pat Brown (30 min.) a. Study design b. Development timeline 2. Blinatumomab update (dosing, toxicity, response, etc.) – Lia Gore (10 min.) 3. Blinatumomab logistics – Brooke Bernhardt (20 min.)

4. HSCT component of AALL1331 – Mike Pulsipher (30 min.) 5. Correlative Studies (10 min. each) a. Infectious toxicity – Sue Rheingold and Sarah Alexander b. Protein stress pathways – Terzah Horton and Sarah Tasian c. Neurocognitive outcomes – Robert Annett

2013 Fall Group Meeting – Dallas, TX ALL Biology/Young Investigator Presentations Chair- Mignon Loh Thursday, October 10 2013 8:00-10:00 a.m. AGENDA

8:00-8:15: “Recurrent translocation involving MLL and AF10 in T cell ALL” Ksenia Matlawska-Wasowska, PhD, Research Assistant Professor, Department of Pediatrics Hematology/Oncology, University of New Mexico Health Sciences Center 8:15-8:30: “Identifying biomarkers to predict sensitivity to Jak inhibitors” Shannon Maude, MD, Ph.D, Instructor, Department of Pediatrics University of Pennsylvania School of Medicine and Children’s Hospital of Philadelphia 8:30-9:00: “CXCR4 as a Mediator of Therapy Resistance in ALL“ Edward Allan R. Sison, MD, Instructor, Oncology and Pediatrics, Johns Hopkins University School of Medicine 9:00-9:30: “Establishment of a Platform for High Throughput Drug Screening on Primary MLLr Infantile ALL Cells” Tanja Gruber, MD, PhD, Assistant Member, Dept. of Leukemia, St. Jude Children's Research Hospital 9:30-10:00: “Inherited GATA3 variants are associated with Ph-like childhood acute lymphoblastic leukemia and risk of relapse” Jun J. Yang Ph.D., Assistant Member, Dept. of Pharm. Science, St. Jude Children's Research Hospital

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:15 Estimated End Time: 8:30 “Identifying biomarkers to predict sensitivity to Jak inhibitors”

2013 Fall Group Meeting – Dallas, TX Myeloid Disease Committee Down Syndrome AML Working Group Chair- Jason Berman, MD, MSc Thursday, October 10, 2013 8:00 a.m. – 10:00 a.m. AGENDA

1. 8:00 to 8:30 – AAML1231 Overview– Jason Berman, Hans Hitzler 2. 8:30 to 10:00 – AAML1231 Open Discussion.

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:00am Estimated End Time: 10:00am AAML1231 Overview and Discussion

2013 Fall Group Meeting – Dallas, TX Myeloid Disease Committee New Agent Subcommittee Chair- Todd Cooper, DO Thursday, October 10, 2013 8:00 a.m. – 10:00 a.m. AGENDA

1. 8:00 to 8:30 – New Agents Overview– Todd Cooper 2. 8:30 to 10:00 – New Agents Open Discussion.

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 8:00am Estimated End Time: 10:00am New Agents Overview and Discussion

2013 Fall Group Meeting – Dallas, TX Pharmacy Research Committee Lee Dupuis, Andrew Ostrenga Thursday, October 10, 2013 12:00 p.m. – 1:00 p.m. AGENDA

1. Pharmacy Research Scholar Program – Lee Dupuis, Andrew Ostrenga (15 min) a. Scope, Purpose and Process

2. Principles of Drug Stability and Compatibility Research – JoEllen Hanigosky (30 min)

3. Pharmacy Research Scholar Program – Lee Dupuis, Andrew Ostrenga (5 min) a. Next Steps 4. Discussion – Lee Dupuis, Andrew Ostrenga (10 min)

2013 Fall Group Meeting – Dallas, TX CYTOGENETICS REVIEW Kathleen W. Rao, Committee Chair Thursday, October 10, 2013 8:00 a.m. – 4:00 p.m. AGENDA

1. Technical Review of Submitted Cases, as needed – Nyla Heerema; Andrew Carroll

2013 Fall Group Meeting – Dallas, TX ________________________________________________________________________ NEUROLOGY DISCIPLINE COMMITTEE (Open) Chair – Nicole Ullrich, MD, PhD Thursday, October 9, 2013 12-1pm AGENDA 1. Introductions Nicole Ullrich

2. Current Neurology efforts within COG a. ACCL 0922: A Phase II Placebo-Controlled Trial of Modafinil to Improve Neurocognitive Deficits in Children Treated for a Primary Brain Tumor b. New concepts: i. Ototoxicity ii. Prevention of cognitive decline c. Long term follow up Guidelines d. Involvement of Neurology Discipline in other cancer control/survivorship/interdisciplinary studies within COG

2013 Fall Group Meeting – Dallas, TX PHARMACY STEERING COMMITTEE Chair- Betsy Bickert Poon Vice-Chair Andrew Ostrenga Thursday, October 10, 2013 1-2 p.m. AGENDA

1. COG Pharmacist Update – Betsy Poon a. Project volunteers i. Chemotherapy Administration Guidelines 1. Priority: carboplatin hypersensitivity management ii. Extravasation Guidelines b. Agent information updates 2. Protocol Review/Protocol Assignment – Andy Ostrenga 3. COG Task Force Initiatives – Betsy Poon a. Chemotherapy Standardization 4. Research Subcommittee- Lee DuPuis/Andy Ostrenga 5. Education- Andrew Ostrenga 6. Disease/Discipline Liaisons 7. Discussion

2013 Fall Group Meeting – Dallas, TX OSTEOSARCOMA Chair- Katherine Janeway Thursday October 10, 2013 1:00 PM – 3:00 PM AGENDA 1. Recently completed studies a. AOST 0331, results of low risk arm – Neyssa Marina

1:00-1:15 PM

2. Proposed studies in recurrent osteosarcoma a. Trial design strategy – Katie Janeway Discussion

1:15-1:25 PM 1:25-1:30 PM

b. Phase II trial of eribulin in recurrent osteosarcoma – Mike Isakoff Local control – Discussion

1:30-1:40 PM

c. Phase II trial of Denosumab in recurrent osteosarcoma – Katie Janeway Local Control -Discussion

1:50-2:00 PM

d. Phase II trial of ch14.18 in Combination with GM-CSF and IL-2 in Patients with Recurrent Osteosarcoma – Pooja Hingorani Local Control – Discussion

2:10-2:20 PM

1:40-1:45 PM 1:45-1:50 PM

2:00-2:05 PM 2:05-2:10 PM

2:20-2:25 PM 2:25-2:30 PM

3. Metastatic osteosarcoma -- Katie Janeway

2:30-2:35 PM

4. Developing Drugs that Target Metastatic Progression in Osteosarcoma – Chand Khanna

2:35-2:45 PM

7. QUADW projects update – Don Barkauskas

2:45–2:55 PM

5. Manuscripts and abstracts a. COG phase II endpoints – Katie Janeway

2:55–3:00 PM

b. Radical vs. wide margins in OS – Lor Randall c. P9754 – Cindy Schwartz

2013 Fall Group Meeting – Dallas, TX STS RADIATION ONCOLOGY Chair- Suzanne Wolden Thursday, October 10, 2013 1:00 p.m. – 3:00 p.m. AGENDA

1. Projects completed, presented, and/or published in the last year 2. Update on protocols a. Next intermediate risk study – Wolden b. ARST1321 (NRSTS with RTOG) - Terezakis c. ARST1332 (proposed high risk RMS study) 3. Status of clinical research projects for the group and/or manuscripts d. D9803 local control – Wolden/Rodeberg e. Orbit dose based on CR/PR – Ermoian/Wolden f. Paratesticular nodal fields – Breneman g. Pilot volumetric response of the embryonal only PM patients - Yock h. Proton comparison – Yock i. ERMS vs UDS using Stanford database/molecular biology to distinguish genes impaired in differentiation - Million 4. QARC reviews a. Suzanne and Torunn available, along with YI

2013 Fall Group Meeting – Dallas, TX ADOLESCENT AND YOUNG ADULT ONCOLOGY DISCIPLINE COMMITTEE GENERAL MEETING Chair- David Freyer Thursday, October 10, 2013 1:00 p.m. – 4:00 p.m. AGENDA 1. Overview of AYA Committee and Major Activities (Freyer) [15 min] 2. Special Presentations a. Results of SMART I Study of Adolescent Resilience and Coping during Bone Marrow Transplantation (Haase/Robb) [30 min including Discussion] b. Intergroup Clinical Trials Development: Lessons Learned from ARST1321RTOG1313 (Weiss) [30 min including Discussion] 3. Ongoing and Planned AYA-focused Analyses [5 min each] a. CNS Tumors (Scientific Liaison: Dhall) i. Medulloblastoma (PI: Farzin-Gohar) ii. Low grade glioma (PI: Margol) b. Myeloid Diseases (Scientific Liaison: Horan) i. Acute promyelocytic leukemia (PI: Sun) c. Hodgkin Lymphoma (Scientific Liaison: Appel) i. ABVE-PC backbone studies (PIs: Punnett/Terezakis/Fernandez) d. Rare Tumors (Scientific Liaison: Pashankar) i. Data analysis and clinical trial plan from MAGIC Collaboration 4. Recent, Ongoing and Developing COG Studies with AYA Relevance [5 min each] a. Survivorship & Outcomes (Scientific Liaison: Freyer) i. ALTE11C1—Ovarian Reserve After Chemo (Levine) ii. ALTE11C2—Cardiac Function After Dexrazoxane (Chow) b. ALL (Scientific Liaison: Raetz) i. C10403 Update (Raetz) 5. Update on AYA Treatment-related Toxicity Initiative (Perentesis/Parsons/O’Brien) [15 min] 6. Inclusion of AYA-relevant symptom reporting in clinical trials (Gupta/Embry) [30 min including Discussion]

2013 Fall Group Meeting – Dallas, TX PRESENTATION TITLE Chair- Logan Spector Thursday, October 10, 2013 2:00 p.m. – 4:00 p.m. AGENDA

1. Studies in analysis – a. AE24 – Epidemiology of infant leukemia (Julie Ross and Todd Druley) b. AEPI04C1 – Low birth weight & other risk factors for hepatoblastoma (Logan Spector) c. AEPI05N1 – Carcinogen metabolism, DNA repair, parental exposures and retinoblastoma (Logan Spector for Greta Bunin) d. AEPI05N2 – Genetic epidemiology of osteosarcoma (Logan Spector) e. E13 – Case-control study of Hodgkin’s disease (Amy Linabery) f. E10 – Case-control study of Rhabdomyosarcoma (Philip Lupo)

2. Studies in recruitment – a. AEPI07N1 – Genetic epidemiology of neuroblastoma (Logan Spector for Andy Olshan) b. AEPI10N1 – Molecular epidemiology of pediatric germ cell tumors (Jen Poynter) c. AEPI10N4 – Molecular and genomic epidemiology of Wilm’s tumor (Rayjean Hung) d. AEPI10N5 – Genetic risk factors for Ewing’s sarcoma (Josh Schiffman)

3. Studies in development a. Rhabdomyosarcoma (Philip Lupo) b. Nasopharyngeal carcinoma (Michael Scheurer) 4. Other issues (Logan Spector) a. CCRN recruitment/EveryChild initiative b. Secondary use of COG data

2013 Fall Group Meeting – Dallas, TX COG ALL Committee Breakouts: Development of a New International Ph+ ALL Trial Chairs- Lewis Silverman and Stephen Hunger Thursday October 10, 2013 2:00 p.m. – 4:00 p.m. AGENDA

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:00 p.m. Estimated End Time: 4:00 p.m. 1. Updates on long term AALL0031 outcomes and TKIs available to treat Ph+ ALL – Kirk Schultz (15 min) 2. AALL0622 update – William Slayton (15 min) 3. AALL1122 update – Stephen Hunger (15 min) 4. Summary of proposed International Trial – Lewis Silverman (15 min) 5. Discussion – all (60 min)

2013 Fall Group Meeting – Dallas, TX Acute Lymphoblastic Leukemia: Outcomes Session Chair- Naomi Winick Thursday October 10, 2013 2:00 p.m. – 4:00 p.m. AGENDA

1. Overview of COG ALL Outcomes Initiatives – Naomi Winick, MD

2. Key questions and opportunities to collaborate with Cancer Control – Lillian Sung, MD, PhD

3. Zamzee Project: Rewards Based Physical Activity Intervention for Children with ALL – Kirsten Ness, PT, PhD

4. Family Life Events in the First Year of Acute Lymphoblastic Leukemia Therapy and outcomes endpoints on AALL0331-Nina Kadan-Lottick, MD, MPH

5. Cogstate Neurocogntive Assessments: COG AALL1131-Kristina Hardy, PhD

2013 Fall Group Meeting – Dallas, TX STEM CELL TRANSPLANT IN ALL Chair- Michael Pulsipher Thursday, October 10, 2013 2:00 p.m. – 4:00 p.m. AGENDA

1. Approach to HSCT for T-ALL a. T-cell ALL therapy in COG—Newly diagnosed and relapse: agents and approaches to transplant – David Teachey b. Outcomes of T-cell ALL transplant—New and old – Mike Burke c. Biology of the GVL effect in T-ALL—Does GVL work in this disease? What biology do we need to know to improve outcomes? – Kirk Shultz d. Discussion of possible approaches

2. Update of HSCT/Cellular Therapy in B-ALL a. COG approaches: Transplant approaches on AALL1331 – Michael Pulsipher a. Early immune suppression withdrawal b. Update on MRD studies c. Discussion of issues b. Update on CART T-cell therapies for ALL – Steve Grupp a. Update on current phase I trial at Penn b. Planned CART 19 studies i. Penn phase II trial ii. BMT CTN relapse after HSCT trial (Penn vector) iii. BMT CTN resistant ALL trial (MSKCC vector)

2013 Fall Group Meeting – Dallas, TX ALL BREAKOUT #9: NEW INTERNATIONAL INFANT ALL TRIAL DEVELOPMENT Chair- Pat Brown Thursday, October 10th, 2013 2:00 p.m. – 4:00 p.m. AGENDA

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 2:00 p.m. Estimated End Time: 4:00 p.m. 1. Overview of International Infant ALL Trial development – Pat Brown (45 min.) a. Proposed study design b. Development timeline c. Logistics of international collaboration d. Potential novel agents 2. Proposal for COG Pilot Study to succeed AALL0631 and precede international study – Erin Guest (45 min.) 3. Open time for Discussion – Group (30 min.)

2013 Fall Group Meeting – Dallas, TX Nursing Discipline: Evidence-Based Practice / Clinical Trials Interactive Session Chairs: Joy Bartholomew and Marcia Leonard Facilitators: Marilyn Hockenberry, Cheryl Rodgers, Janice Withycombe, and Wendy Landier Thursday, October 10, 2013 2:00 pm – 4:00 pm AGENDA 1. Introduction (2:00 – 2:05) – Joy Bartholomew and Marcia Leonard 2. EBP Overview (2:05 – 2:20) – Marilyn Hockenberry a. Overview of EBP initiative b. Discussion of EBP workshop and plans for publication 3. 2013 EBP Projects (2:20 – 3:20) – Cheryl Rodgers and Janice Withycombe a. Identification of evidence-based practices to prevent/manage post lumbar puncture headaches in pediatric patients receiving intrathecal chemotherapy presented by Rebecca Rusch and Christina Schulta b. Developing evidence-based guidelines for standard hydration for children/adolescents with cancer receiving intravenous cyclophosphamide presented by Ginny Schultz c. Establishing evidence-based guidelines for fertility preservation options for inclusion in treatment protocols for pediatric and adolescent patients diagnosed with cancer presented by Alison Fernbach 4. Patient/Family Education in Pediatric Oncology Initiative (3:20 – 3:35) – Wendy Landier a. Overview of patient/family education b. COG nurse fellowships in evidence-based practice: “Understanding Effective Delivery of Patient/Family Education in Pediatric Oncology” 5. Upcoming EBP Initiative (3:35 – 3:45) – Cheryl Rodgers and Janice Withycombe a. Discussion of plans and opportunities for patient/family education in pediatric oncology initiative 6. Concluding Remarks (3:45-3:50) – Joy Bartholomew and Marcia Leonard

2013 Fall Group Meeting – Dallas, TX BEHAVIORAL SCIENCE COMMITTEE Chair- Robert Noll Thursday, October 10, 2013 2:00 p.m. – 6:00 p.m. AGENDA 1. Current Status of BSC within COG – Robert Noll a. How to facilitate more participation from junior colleagues b. Current and planned pediatric oncology behavioral science grants 2. ALTE07C1 Update – Leanne Embry, Stephen Sands, Rob Annett, Sunita Patel, Kristi Hardy a. Review of all open studies b. Planned studies 3. Assessment of cognition in a pediatric clinical trials setting using Cogstate: Present and future developments – Brian Harel 4. ACNS0331 – Kristi Hardy and Leanne Embry a. Initial findings 5. CCG-105NP Update of findings – Rob Annett 6. BREAK 3:45 p.m. – 4:00 p.m. 7. Psychosocial Standards of Care – Robert Noll, Wendy Pelletier, and Andrea Patenaude a. COG Supportive Care Committee b. AGREE II c. Standards versus Guidelines 8. Mattie Miracle Foundation – Peter and Vicki Brown 9. Work accomplished related to psychosocial standards of care a. Neuropsychological assessments – Rob Annett and Sunita Patel b. School – Robert Noll c. Assessment – Anne Kazak d. Staff and Documentation– Andrea Patenaude e. Interventions – Lori Wiener

2013 Fall Group Meeting – Dallas, TX STS RADIATION ONCOLOGY Chairs- Suzanne Wolden, Dave Rodeberg Thursday, April 10, 2013 3:00 p.m. – 4:00 p.m. AGENDA

1. Plans for next intermediate risk study a. Role of SLO b. Retroperitoneal tumors 2. Active manuscripts a. D9803 local control /SLO – Wolden/Rodeberg b. Others

2013 Fall Group Meeting – Dallas, TX RMS Pathology/Biology Breakout Session Chair – Stephen Skapek Thursday, October 10, 2013 3:00 p.m. – 5:00 p.m. AGENDA

Topics for Discussion – Barr, Skapek and others (1 hour) Short talks: 1) Javed Khan – Update on RMS NGS results 2) Charles Keller – IL-4 receptor blockade in satellite cells and RMS 3) Erin Rudzinski – IHC as molecular classification surrogate 4) Corinne Lindardic – RMS cell lines – problem of mistaken identity

2013 Fall Group Meeting – Dallas, TX Soft Tissue Sarcoma Committee: Chemotherapy Breakout Session Chair- Sheri Spunt Thursday, October 10, 2013 3:00 p.m. – 6:00 p.m. AGENDA

3:00 – 3:30 pm

Notch inhibitor for desmoid fibromatosis – Abha Gupta

3:30 – 4:00 pm

New high risk RMS study – Douglas Harrison

4:00 – 4:45 pm

New intermediate risk RMS study – Abha Gupta

4:45 – 5:15 pm

Treatment assignment for fusion negative metastatic RMS – Rajkumar Venkatramani

5:15 – 6:00 pm

New RMS relapse study – Jodi Muscal

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 3:00 pm Estimated End Time: 6:00 pm All agenda items include discussion of investigational drugs

2013 Fall Group Meeting – Dallas, TX NURSING CONTINUING EDUCATION AND PLENARY SESSION Chairs – Wendy Landier & Maureen Haugen Thursday, October 10, 2013 4:00 – 6:00 pm AGENDA 4:00 – 5:00pm Continuing Education Session (1 CEU credit) Maureen Haugen, Education Subcommittee Chair “Cytogenetics for the COG Nurse” Joy Bartholomew, RN, FNP-BC, CPHON®

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 4:00 PM Estimated End Time: 5:00 PM Presentation: Cytogenetics for the COG Nurse This activity has been submitted to the Oncology Nursing Society for approval to award contact hours. ONS is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s COA.

-------------------------------------------------------------------------------------------------------------5:00 – 6:00pm Nursing Discipline Plenary Session Wendy Landier, Chair; Marcia Leonard, Vice Chair - Announcements - Discipline Progress - Study Outcomes: Joan Haase, PhD, RN, FAAN and Sheri Robb, PhD, MT-BC: Report on Outcomes of ANUR0631: A Randomized Clinical Trial of Therapeutic Music Video Intervention for Resilience Outcomes in Adolescents/Young Adults Undergoing Hematopoietic Stem Cell Transplant - Traineeship Updates: Jessica Ward: Stress Experienced by Parents of Children Recovering from the Acute Phase of HSCT Brandy Winkle: Vincristine-Related Toxicity in Children Treated for ALL on CCG-1961 - Recognition

OPEN NURSING MEETING ---- All nurses invited to attend & participate

2013 Fall Group Meeting – Dallas, TX Radiation Oncology Discipline Committee Meeting Chair- Thomas E. Merchant, DO, PhD Thursday, October 10, 2013 4:00 p.m. – 7:00 p.m. AGENDA

1. Chair Report and COG Blueprint for Radiation Oncology Research Thomas E. Merchant, DO, PhD – St. Jude Children’s Research Hospital 2. Update on Proton Therapy Center Approvals David Followill, PhD – Radiological Physics Center/ MD Anderson Cancer Center 3. Pediatric Radiation Oncology in Low- and Middle-Income Countries-Why We Should Get Involved? Natia Esiashvili, MD - Winship Cancer Institute of Emory University 4. RT Guidelines for ARST1321-RTOG1313: Pazopanib Neoadjuvant Trial in NonRhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS) Stephanie Terezakis, MD - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

2013 Fall Group Meeting – Dallas, TX

Joint Canadian CRAs and Pharmacists Meeting Chair- Kathy Brodeur-Robb Thursday, October 10, 2013 4:00p.m. – 7:00 p.m. AGENDA Meeting Goal: To connect with fellow CRAs and Pharmacists to share and problem solve some of the operational and regulatory challenges facing Canadian sites. 1. Meeting Introductions and Goals – Kathy Brodeur-Robb 2. CRAs and Pharmacists – Discussion Groups a. Communication between CRAs and Pharmacists     3.

Enrolling Patients onto Trials Regulatory Requirements for Drug Accountability of HC Investigational Agents Home Medications Reconciling Treatment Documentation e.g. Roadmaps

CRA’s Monitoring Pharmacy

Break Out Groups 4. CRAs – Regulations vs. SOPs – What Guides Our Behavior a. Delegation Logs – Who’s on and Who’s Not b. Regulatory Documentation – Post NOL c. Study Closure at Sites – Regulatory Requirements 5.

Pharmacists a. Goals for the Pharmacy CoP 2014 b. Operationalizing Clinical Trials In Pharmacy c. BPMH (Best Possible Medication History) forms

Certificates of Training will be available for all those who attend; attendance will fulfill requirements for SOCRA CEUs

2013 Fall Group Meeting – Dallas, TX PHARMACY COMMITTEE Chair- Betsy Bickert Poon Vice-Chair Andrew Ostrenga Thursday, October 10, 2013 6-9 p.m. AGENDA

1. Introductions – Betsy Poon 2. COG Pharmacist Update – Betsy Poon a. Project volunteers i. Chemotherapy Administration Guidelines 1. Priority: carboplatin hypersensitivity management ii. Extravasation Guidelines b. Agent information updates 3. Protocol Review/Protocol Assignment – Andy Ostrenga/Theresa Kressaty a. Disease Group Interest List 4. COG Task Force Initiatives – Betsy Poon a. Chemotherapy Standardization 5. Research Subcommittee- Lee DuPuis/Andy Ostrenga a. Pharmacy Research Scholar Program i. Pharmacy Scholar: Joellen Hanigosky ii. Pharmacy Mentor: Petrea Cober 6. Education- Andrew Ostrenga 7. Membership – Jennifer Collura Raltz 8. Disease/Discipline Liaisons 9. Discussion

2013 Fall Group Meeting – Dallas, TX

NURSING DISCIPLINE STEERING COMMITTEE (CLOSED MEETING)

Chair- Wendy Landier Vice Chair-Marcia Leonard Thursday, October 10, 2013 7:00 p.m. – 9:00 p.m.

AGENDA 1. Administrative – Wendy Landier 2. Education – Maureen Haugen, Katy Murphy 3. Members-At-Large – Katy Murphy, Jenn Wofford 4. Clinical Trials – Joy Bartholomew, Marcia Leonard, Micah Skeens 5. Research – Kathy Kelly, Casey Hooke 6. Communications – Kathy Ruccione

2013 Fall Group Meeting – Dallas, TX CANCER CONTROL AND SUPPORTIVE CARE STEERING COMMITTEE Chair- Lillian Sung AGENDA CRA Education Session Friday, October 11, 2013 11:00 a.m. – 12:00 p.m. 1. Facilitating Accrual to Cancer Control and Supportive Care Trials: The Clinical Research Associate Perspective (David Vanhoff) (11:00) 2. ACCL0922 (Nicole Ullrich) (11:15) 3. ACCL0933 (Colleen Callahan) (11:25) 4. ACCL0934 (Sarah Alexander) (11:35) 5. ACCL1131 (Christopher Dvorak) (11:45)

2013 Fall Group Meeting – Dallas, TX Bioethics Steering Committee Chair- Steven Joffe, MD, MPH Friday, October 11, 2013 7:00 a.m. – 8:30 a.m. AGENDA

1. Introduction – Steven Joffe, MD, MPH (7:00 am – 7:05 am)

2. Overcoming Challenges to Meaningful Informed Consent for Whole Genome Sequencing in Pediatric Oncology – Jennifer Levine, MD, Julia Glade Bender, MD and Jennifer Oberg, MD (7:05 am to 7:40 am)

3. Interventions to improve outcomes for siblings of patients undergoing stem cell transplantation – Rebecca Pentz, PhD (7:40 am to 8:15 am)

2013 Fall Group Meeting – Dallas, TX SCIENTIFIC CHAIRS (closed meeting) Chair- Doug Hawkins Friday October 11, 2013 7:00 a.m. – 9:00 a.m. AGENDA 1. Anticipated funding from new grant: Adamson

7:00-7:15

2. Concept reviews by steering committees: Adamson

7:15-7:30

3. Biology study (EveryChild initiative): Adamson

7:30-7:45

4. Standardized BIQSFP applications: Kolb

7:45-8:00

5. Publications Office: Adamson

8:00-8:10

6. Metadata implementation: Devidas

8:10-8:20

7. Future of epidemiology studies in COG: Spector

8:20-8:30

8. CTRP reporting requirements for study objectives: Blaney

8:30-8:40

2013 Fall Group Meeting – Dallas, TX Nursing Clinical Trials Subcommittee: Disease and Protocol Committee Nurses Meeting Chairs - Marcia Leonard, Micah Skeens, Joy Bartholomew Friday, October 11, 2013 8:00 am – 9:00 am

AGENDA

1. Introduction - Marcia Leonard & Micah Skeens a. Welcome b. Overview of meeting c. Leadership transition

2. Interactive Discussion a. Role of the nurse on COG Disease, Specialty & Protocol Committees b. Disease Committee nurses c. Opportunities for new nurse involvement

3. Small Group Discussions a. Disease Committee nurses pair with protocol nurses b. Specialty Nurses group

OPEN NURSING MEETING – All nurses assigned to committees or protocols and nurses interested in future committee assignments are welcome to attend

2013 Fall Group Meeting – Dallas, TX CRA Education Chair- Sally Muehle Friday, 9/11/2013 8a.m. – noon AGENDA

1. 8 a.m. - 10 a.m. CRA Education a. Poster Presentation Dawn Borgerson b. CRA Retention Emily Owens-Pickle/ Dawn Borgerson c. ACNS1221 Dr. Lafay-Cousin 2. 10a.m. – 11 a.m. CRA Education Breakout sessions a. Session 1 i. ALTE11C2 Dr. Chow ii. ALTE05N1 Molly Mather/Lindsey Hageman iii. ALTE11C1 Dr. Levine/Trisha Ali-Shaw b. Session 2 i. Monitoring Adverse Events via Toxicity Spread Sheets: One Institution’s Systematic Approach- Gina Filley 3. 11a.m. – noon CRA Education Breakout sessions a. Session 3 i. Internal Audits and Quality Assurance –Jill Woodman/Yolanda Santiago b. Session 4 i. ACCL0922 Dr. Ulrich ii. ACCL0933 Dr. Fisher iii. ACCL0934 Dr. Alexander iv. ACCL1131 Dr. Dvorak v. Facilitating Accrual to Cancer Control & Supportive Care Trials: The Clinical Research Associate Perspective David VanHoff

2013 Fall Group Meeting – Dallas, TX Bioethics Committee Open Meeting Chair- Steven Joffe, MD, MPH Friday, October 11, 2013 8:30 a.m. – 10:00 a.m. AGENDA

1. Return of individual genomic results from research on biobanked specimens – Steven Joffe, MD, MPH (8:30 – 8:45)

2. Update on return of study results website and committee – Conrad Fernandez, MD (8:45 – 8:50)

3. Working Group on Chemotherapy Shortages – Yoram Unguru, MD (8:50 – 9:20)

4. Adolescent & Young Adult Committee Update – Greg Guilcher, MD (9:20 – 9:25)

5. Psychosocial standards for pediatric cancer care – Andrea Patenaude, PhD (9:25 – 9:45)

6. Input to Presidential Bioethics Commission on Privacy and Progress – Steve Joffe, MD, MPH (9:45 – 10:00)

2013 Fall Group Meeting – Dallas, TX NURSING RESEARCH-SCHOLARS SESSION Nursing Research Co-Chairs: Kathy Kelly & Casey Hooke Friday, October 11, 2013 9:00 am – 11:00 am AGENDA 9:00 - 9:10

Welcome

Kathy Kelly & Casey Hooke

9:10 - 9:25

Update from NCI

Ann O’Mara

9:25 - 9:35

Updates from the Nursing Discipline Chair

Wendy Landier

9:35 - 9:50

Open Study Update Joan Haase, Sheri Robb ANUR1131: Palliative Cancer Care: Music Video for AYA-Parent Communication and Resilience

9:50 - 10:10

New Concept - Discussion Tina Baggott The Quantified Self in Pediatric Oncology: Coupling Biologic Factors with Self-tracking to Predict Symptom Trajectories

10:10 - 10:30

New Concept - Discussion Celeste Phillips-Salami Resilience Profile for Adolescents/Young Adults with Cancer and Their Parents

10:30 - 10:50

Embedded Concept – Lessons Learned, Discussion Neurobehavioral Symptoms in Children and Adolescents with Hodgkin Lymphoma

10:50 - 11:00

Questions/Discussion

Casey Hooke

OPEN MEETING ---- All are invited to attend and participate

2013 Fall Group Meeting – Dallas, TX SOFT TISSUE SARCOMA COMMITTEE Chair- Doug Hawkins Friday October 11, 2013 9:00 a.m. – Noon AGENDA 1. Closed study updates a. ARST0332 (non-RMS STS): Sheri Spunt c. ARST0531 (intermediate-risk RMS): Doug Hawkins d. ARST08P1 (high-risk RMS): Suman Malempati e. ARST0921 (relapsed RMS): Leo Mascarenhas

9:00-9:10 9:10-9:20 9:20-9:35 9:35-10:00

2. Selected topics a. EpSSG update: Véronique Minard-Colin b. Future workshop: Leo Mascarenhas

10:00-10:20 10:20-10:30

3. Planned studies a. ARST1321 (new non-RMS STS): Aaron Weiss b. ARST1333 (new intermediate RMS): Abha Gupta c. ARST1332 (new high risk RMS): Doug Harrison

10:30-10:45 10:45-11:00 11:00-11:15

4. Reports from breakout sessions a. Radiation oncology: Suzanne Wolden b. Biology/Pathology: Steve Skapek c. Surgery: Dave Rodeberg c. Chemotherapy: Sheri Spunt

11:15-11:25 11:25-11:35 11:35-11:45 11:45-11:55

Discussion of Investigational Drugs: Closed to Industry Representatives Estimated Start Time: 9:00 Estimated End Time: 11:15 ARST08P1 (high-risk RMS): Suman Malempati (IMC-A12) ARST0921 (relapsed RMS): Leo Mascarenhas (temsirolimus, bevacizumab) ARST1321 (NRSTS): Aaron Weiss (Pazopanib) ARST1333 (intermediate risk RMS): Abha Gupa (temsirolimus) ARST1332 (high risk RMS): Doug Harrison (Pazopanib)

2013 Fall Group Meeting – Dallas, TX Pathology Discipline Meeting- Dallas Tx Chair- John Hicks Friday, October 11, 2013 9:00 a.m. – 12:00 p.m. AGENDA

1. Update on Pediatric Renal Tumors – Elizabeth Perlman 2. Young Investigator Mentoring Program Update and Presentations – Chris Pierson A. YI Projects and Mentors B. What worked, what did not work from both the mentor and mentees perspectives. 3. Membership Committee Report – Jennifer Black 4. Institutional Performance and Monitoring Committee – Erin Rudzinski 5. Biopathology Center Report – Nilsa Ramirez 6. VIPER & Digital Imaging/Review: Biopathology Center 7. COG Update Education Session Presented at SPP Interim Meeting in Salt Lake City September 2013: Pathology of Peripheral Neuroblastic Tumors: Past, Present and Future – Jason Jarzembowski. 8. Probably No COG Update Education Session at Joint SPP and PPS Meeting, September 4-6, 2014 Birmingham UK. 9. COG Travel Funding for Pathology Discipline - John Hicks 10. Update on COG Executive Council Items and Other Business – John Hicks