Childhood Cancer Clinical Trials in Georgia

Childhood Cancer Clinical Trials in Georgia 50 Hurt Plaza, Suite 704 Atlanta GA 30303 T 404.523.8735 F 404.584.8839 www.georgiacore.org www.GeorgiaCa...
Author: Myra Allen
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Childhood Cancer Clinical Trials in Georgia

50 Hurt Plaza, Suite 704 Atlanta GA 30303 T 404.523.8735 F 404.584.8839 www.georgiacore.org www.GeorgiaCancerTrials.org

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus Sidny Midoro (404) 785-1441

Cancer Type

Clinical Trial Number

Clinical Trial Title

Bone

AOST06P1

Feasibility and Dose Discovery Analysis of Zoledronic Acid With Concurrent Chemotherapy in the Treatment of Newly Diagnosed Metastatic Osteosarcoma

Bone

AP23573-7-110

A Multi-Center Phase I Study of Intravenous Deforolimus (AP23573, MK-8669) Administered QDX5 Every Other Week in Pediatric Patients With Advanced Solid Tumors

Bone

COG-ADVL0821

A Phase II Study of IMC-A12 (Anti-IGF-I Receptor Monoclonal Antibody, IND #100947, NSC #742460) in Children With Relapsed/Refractory Solid Tumors

Bone

COG-ASCT0521

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Acute NonInfectious Pulmonary Dysfunction (Idiopathic Pneumonia Syndrome) Following Allogeneic Stem Cell Transplantation

Bone

P04720

A Study to Determine the Activity of SCH 717454 in Subjects With Osteosarcoma or Ewing's Sarcoma That Has Relapsed After Standard Systemic Therapy

Today’s cancer care. Tomorrow’s cancer cure.

1

Childhood Cancer Clinical Trials in Georgia Brain

2004-03

A Phase I Study of Intravenous (Emulsion) Fenretinide in Children with Recurrent or Resistant Neuroblastoma

Brain

COG-ACNS0221

A Phase II Study of Conformal Radiotherapy In Patients With Low-Grade Gliomas

Brain

COG-ACNS02B3

A Children's Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens

Brain

COG-ACNS0331

A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Brain

COG-ACNS 0332

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a ProApoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Brain

COG-ACNS0621

Cilengitide (EMD 121974) (IND# 59073) in Recurrent or Progressive and Refractory Childhood High-Grade Glioma

Brain

NANT-2001-02

I-Metaiodobenzylguanidine (MIBG) With Intensive Chemotherapy and Autologous Stem Cell Rescue for High-Risk Neuroblastoma

Brain

NANT-2001-03

A Phase I Study Of CEP-701 In Patients With Refractory Neuroblastoma (IND # 67,722)

Today’s cancer care. Tomorrow’s cancer cure.

2

Childhood Cancer Clinical Trials in Georgia Brain

NANT-2004-03

A Phase I Study of Intravenous (Emulsion) Fenretinide in Children With Recurrent or Resistant Neuroblastoma

Brain

NANT-2004-06

Irinotecan and Vincristine With 131I-MIBG Therapy for Resistant/Relapsed High-Risk Neuroblastoma, A Phase I Study

Kidney

199-96

National Wilm's Tumor Study Late Effects

Kidney

COG-AREN0321

Treatment of High Risk Renal Tumors

Kidney

COG-AREN03B2

Renal Tumors Classification, Biology, and Banking Study

Kidney

COG-AREN0533

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Leukemia

ACCL0731

Glutamic Acid to Decrease Vincristine Toxicity in Children With Cancer [ACCL0731]

Leukemia

COG-AALL0232

High Risk B-Precursor Acute Lymphoblastic Leukemia

Today’s cancer care. Tomorrow’s cancer cure.

3

Childhood Cancer Clinical Trials in Georgia Leukemia

COG-AALL0331

Standard Risk B-precursor Acute Lymphoblastic Leukemia

Leukemia

COG-AALL03B1

Classification Of Acute Lymphoblastic Leukemia

Leukemia

COG-AALL03N1

Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL

Leukemia

COG-AALL0433

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Leukemia

COG-AALL0434

Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia

Leukemia

COG-AALL0622

Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Leukemia

COG-AALL0631

A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; IND#76431; NSC#617807)

Leukemia

COG-AALL06N1

A Study of Neurocognitive Function in Children Treated for ALL

Today’s cancer care. Tomorrow’s cancer cure.

4

Childhood Cancer Clinical Trials in Georgia Leukemia

COG-ALTE03N1

Key Adverse Events After Childhood Cancer

Leukemia

CLO08808

A Phase 1, Open-Label, Multi-Center Safety and Tolerability Pilot Combination Study of Clofarabine, Etoposide, Cyclophosphamide, PEG-asparaginase, and Vincristine in Pediatric Patients With Acute Lymphoblastic Leukemia (ALL) in First Relapse

Leukemia

COG-AAML0431

The Treatment of Down Syndrome Children With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS) Under the Age of 4 Years

Leukemia

COG-AAML0631

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation

Leukemia

COG-AAML08B1

Biology Study of Transient Myeloproliferative Disorder (TMD) in Children With Down Syndrome (DS)

Leukemia

COG-ALTE05N1

Umbrella Long-Term Follow-Up Protocol

Leukemia

FRAG-A001-201

A Three Month Prospective Open Label Study Of Therapy With Fragmin (Dalteparin Sodium Injection) In Children With Malignancies And Venous Thromboembolism

Leukemia

Sirolimus

A Phase I Study of Sirolimus With PEG-Asparaginase in Multiple Recurrent or Refractory Childhood Acute Lymphoblastic Leukemia

Today’s cancer care. Tomorrow’s cancer cure.

5

Childhood Cancer Clinical Trials in Georgia Liver

230-2005

Hepatoblastoma Biology Study and Tissue Bank

Lymphoma

ACRIN-6660

Whole-Body MRI in the Evaluation of Pediatric Malignancies

Lymphoma

AHOD03P1

Treatment of Children With Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Lymphoma

COG-AHOD04B1

Hodgkin Disease (HD) Banking Study

Lymphoma

COG-ANHL04B1

Rare And Cutaneous Non-Hodgkin Lymphoma Registry

AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta – Scottish Rite Campus Sidny Midoro (404) 785-1441 Cancer Type

Clinical Trial Number

Clinical Trial Title

Brain

NANT-N2004-04

Phase I Study of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder in Patients with Recurrent or Resistant Neuroblastoma

Today’s cancer care. Tomorrow’s cancer cure.

6

Childhood Cancer Clinical Trials in Georgia

Emory University Clinical Trials Office (404) 785-0853 Cancer Type

Clinical Trial Number

Clinical Trial Title

Bone

COG-AEWS07B1

A COG Study for Collecting and Banking Ewing Sarcoma Specimens

Bone

COG-AOST0331

A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to PreOperative Chemotherapy - A Phase III Intergroup Study

Bone and Soft Tissue

COG-D9902

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Brain

COG-ACNS 0332

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Brain

COG-ANBL0032

Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Brain

COG-ANBL0531

Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Eye

COG-ARET0332

A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy

Kidney

COG-AREN0532

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Today’s cancer care. Tomorrow’s cancer cure.

7

Childhood Cancer Clinical Trials in Georgia Leukemia

COG-AAML07P1

A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia

Leukemia

COG-AGCT0132

A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Leukemia

COG-ARST0331

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Leukemia

COG-ADVL04P2

A Feasibility Pilot and Phase 2 Study Of Chemoimmunotherapy With Epratuzumab For Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia

Leukemia

COG-AAML0531

A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Lymphoma

COG-AHOD03P1

Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Unspecified

COG-AALL03N1

Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL

Unspecified

COG-ALTE03N1

Key Adverse Events After Childhood Cancer

Medical College of Georgia Cancer Center Colleen H. McDonough (706) 721-3626 Cancer Type

Clinical Trial Number

Today’s cancer care. Tomorrow’s cancer cure.

Clinical Trial Title

8

Childhood Cancer Clinical Trials in Georgia Bone

COG-AOST0331

A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to PreOperative Chemotherapy - A Phase III Intergroup Study

Bone and Soft Tissue

COG-D9902

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Brain

COG-AGCT0132

A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Brain

COG-ANBL0531

Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Kidney

COG-AREN03B2

Renal Tumors Classification, Biology, and Banking Study

Kidney

COG-AREN0532

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Leukemia

COG-ARST0331

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Leukemia

COG-AAML0531

A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Unspecified

COG-AALL03N1

Understanding the Role of Adherence in the Ethnic Differences in Survival After Childhood ALL

Unspecified

COG-ALTE03N1

Key Adverse Events After Childhood Cancer

Memorial Health University Medical Center Patricia Sharpe (912) 350-8707 Cancer Type

Clinical Trial Number

Today’s cancer care. Tomorrow’s cancer cure.

Clinical Trial Title

9

Childhood Cancer Clinical Trials in Georgia Bone

VU-VICC-PED0711

Erwinase Master Treatment Protocol - Erwinia L-Asparaginase for Injection

Bone

COG-AEWS07B1

A COG Study for Collecting and Banking Ewing Sarcoma Specimens

Bone

COG-AOST0331

A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to PreOperative Chemotherapy - A Phase III Intergroup Study

Bone and Soft Tissue

COG-D9902

A COG Soft Tissue Sarcoma Diagnosis, Biology and Banking Protocol

Brain

COG-ACNS 0332

Efficacy of Carboplatin Administered Concomitantly With Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

Brain

COG-AGCT0132

A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Brain

COG-ANBL0032

Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

Brain

COG-ACNS0331

A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal (18.00 Gy) and Chemotherapy in Children With Newly Diagnosed Standard Risk Medulloblastoma: A Phase III Double Randomized Trial

Brain

COG-ALTE07C1

Neuropsychological, Social, Emotional, and Behavioral Outcomes in Children With Cancer

Brain

COG-ANBL0531

Response- and Biology-Based Therapy for Intermediate-Risk Neuroblastoma

Eye

COG-ARET0332

A Study of Unilateral Retinoblastoma With and Without Histopathologic High-Risk Features and the Role of Adjuvant Chemotherapy

Kidney

199-96

National Wilm's Tumor Study Late Effects

Today’s cancer care. Tomorrow’s cancer cure.

10

Childhood Cancer Clinical Trials in Georgia Kidney

COG-AREN03B2

Renal Tumors Classification, Biology, and Banking Study

Kidney

COG-AREN0533

Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms Tumors

Kidney

COG-AREN0321

Treatment of High Risk Renal Tumors

Kidney

COG-AREN0532

Treatment for Very Low and Standard Risk Favorable Histology Wilms Tumor

Leukemia

COG-AALL03B1

Classification Of Acute Lymphoblastic Leukemia

Leukemia

COG-AALL0622

Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib: IND# 73969, NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

Leukemia

COG-AAML07P1

A Phase II Pilot Study of Bortezomib (PS-341, Velcade) Combined With Reinduction Chemotherapy in Children and Young Adults With Recurrent, Refractory or Secondary Acute Myeloid Leukemia

Leukemia

COG-ARST0331

Vincristine, Dactinomycin, and Lower Doses of Cyclophosphamide With or Without Radiation Therapy for Patients with Newly Diagnosed Low-Risk Embryonal/Botryoid/Spindle Cell Rhabdomyosarcoma

Leukemia

COG-AAML0631

Risk Adapted Treatment of Newly Diagnosed Childhood Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide (Trisenox® IND #103331) During Consolidation

Leukemia

COG-AALL0434

Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia

Leukemia

COG-AALL0433

Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

Today’s cancer care. Tomorrow’s cancer cure.

11

Childhood Cancer Clinical Trials in Georgia Leukemia

COG-ADVL04P2

A Feasibility Pilot and Phase 2 Study Of Chemoimmunotherapy With Epratuzumab For Children With Relapsed CD22-Positive Acute Lymphoblastic Leukemia

Leukemia

COG-ABTR01B1

A Children's Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens

Leukemia

COG-AAML0531

A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Mylotarg) Combined With Conventional Chemotherapy for De Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Lymphoma

COG-AHOD03P1

Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease (LPHD)

Lymphoma

COG-ANHL04B1

Rare And Cutaneous Non-Hodgkin Lymphoma Registry

Soft Tissue

COG-ARST0531

Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine and Irinotecan (VI) for Patients With Intermediate-Risk Rhabdomyosarcoma (RMS)

Today’s cancer care. Tomorrow’s cancer cure.

12