Pediatric Cancer Research

Peyton Manning Children’s Hospital

To learn more about pediatric cancer studies at Peyton Manning Children’s Hospital, contact Dr. Bassem Razzouk at 317-338-4673 or Linda Cheatham at 317-338-9825 to discuss your child’s needs.

Peyton Manning Children's Hospital - Project: Every Child

Local Care with National Connections

Children’s Center for Cancer and Blood Diseases at Peyton Manning Children’s Hospital at St.Vincent is a member of the Children’s Oncology Group (COG), the premier children’s cancer network. In addition, St.Vincent is the only Indiana hospital selected by the National Cancer Institute to participate in the pilot phase of a new program to coordinate state-of-the-art cancer care in community hospitals across the United States.

Everything now known about the cure of children with cancer has been learned from research.  The COG grew out of several cooperative research groups established by the National Cancer Institute in 1955.  The COG is a national clinical research consortium made up of more than 200 pediatric cancer centers.  COG members have been the primary innovators in new treatments for children with cancer.

Our physicians hold leadership roles in the COG.  Because we are a participating center, all of our patients are eligible for treatment protocols used by the COG.  Our center has an average of 55 active clinical trials available to patients, including epidemiology and late effects studies. Epidemiology studies allow researchers to gather information from several families to find patterns between potential risk factors they have been exposed to and the cancer.  Late effects studies look at complications that may occur years after receiving cancer treatment.

In addition to the COG trials, we are involved with The Severe Chronic Neutropenia International Registry, an organization dedicated to improving understanding and treatment for diseases causing severe chronic neutropenia. The registry was initiated under sponsorship from Amgen in 1994 to monitor the clinical course and long-term treatment of patients with severe chronic neutropenia after controlled clinical trials demonstrated the effectiveness of granulocyte colony-stimulating factor (G-CSF) for the treatment of these conditions. In July 2000, the Amgen Foundation became the principal sponsor of the registry, with additional support from private and governmental sources.

We also participate in industry-sponsored trials.  We are one of 16 sites nationwide to be approved for Phase II of A Phase I/II Dose-Escalation Study of Clofarabine in Combination with Etoposide and Cyclophosphamide in Pediatric Patients with Refractory or Relapsed Acute Leukemias.  This study is sponsored by Genzyme Corporation. Although Clofarabine is approved by the FDA for treatment of leukemia, it has not been given with etoposide and cyclophosphamide before this study. This study will help determine the right dose of each of these three drugs when given together, the side effects when these three drugs are given together, how long clofarabine stays in the body when given with these two other drugs and the efficacy of giving these three drugs together.

The following is a list of open clinical trials available at the Children’s Center for Cancer and Blood Diseases. The list is constantly changing, so please contact Dr. Bassem Razzouk at 31-7338-4673 or Linda Cheatham at 317-338-9825 to discuss your child’s needs.  You may access information about these COG trials at http://www.curesearch.org.

Clinical Trials

Leukemia – Acute Lymphoblastic Leukemia (ALL)

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)

AALL0331:  Standard Risk B-precursor Acute Lymphoblastic Leukemia

AALL02P2:  Treatment of Late Isolate Extramedullary Relapse from Acute Lymphoblastic Leukemia (Initial CR1 > 18 months)

AALL0232:  High Risk B-precursor Acute Lymphoblastic Leukemia

AALL0434:  Intensified Methotrexate, Nelarabine (Compound 506U78; IND #52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed
T-Cell Lymphoblastic Leukemia)

AALL03N1:  Understanding the Role of Adherence in the Ethnic Differences in Survival after Childhood ALL

AALL06N1:  A Study of Neurocognitive Function in Children Treated for ALL

AALL05B1:  A Children’s Oncology Group Protocol for Collecting and Banking Relapsed Acute Lymphoblastic Leukemia Research Specimens

AALL03B1:  Classification of Acute Lymphoblastic Leukemia

Leukemia — Acute Myelogenic Leukemia (AML)

AAML0431:  The Treatment of Down Syndrome Children with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) under the Age of 4 Years

AAML0531:  A Phase III Randomized Trial of Gemtuzumab Ozogamicin (Myolarg) Combined with Conventional Chemotherapy for DeNovo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults

Neuroblastoma

ANBL0032:  Phase III Randomized Study of Chimeric Antibody 14.18 (Ch14.18) in High Risk Neuroblastoma Following Myeloablative Therapy and Autologous Stem Cell Rescue

ANBL00B1:  Neuroblastoma Biology Studies

ANBL00P2:  Perinatal Neuroblastoma:  Expectant Observation

Wilms’/Kidney Tumor

AREN0532:  Treatment for Very Low, Low and Standard Risk Favorable Histology Wilms’ Tumor

AREN03B2:  Renal Tumors Classification, Biology and Banking Study

AREN0533:  Treatment of Newly Diagnosed Higher Risk Favorable Histology Wilms’ Tumors

AREN0321:  Treatment of High Risk Renal Tumors

Lymphoma

ANHL04B1:  Rare and Cutaneous Non-Hodgkin Lymphoma Registry

ANHL0131:  A Phase III Trial of Treatment of Advanced-Stage Anaplastic Large Cell Lymphoma (ALCL) with Standard APO (Doxorubicin, Prednisone, Vincristine) versus Consolidation with a Regimen Including Vinblastine

ANHL01P1:  A Pilot Study to Determine the Toxicity of the Addition of Rituximab to the Induction and Consolidation Phases and the Addition of Rasburicase to the Reduction Phase in Children with Newly Diagnosed Advanced B-Cell Leukemia/Lymphoma Treated with LMB/FAB Therapy

Hodgkin Disease

AHOD0031:  A Phase III Group-Wide Study of Dose-Intensive response-Based Chemotherapy and Radiation Therapy for Children and Adolescents with Newly Diagnosed Intermediate Risk Hodgkin Disease

AHOD03P1:  Treatment of Children with Newly-Diagnosed Low Stage Lymphocyte Predominant Hodgkin Disease

AHOD0431:  A Phase III Study for the Treatment of Children and Adolescents with Newly Diagnosed Low Risk Hodgkin Disease

AHOD0521:  A Phase II Study of Bortezomib (Velcade, PS-341, IND #58443) in Combination with Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults with Refractory/Recurrent Hodgkin Disease

AHOD04B1:  Banking in Hodgkin Disease

Soft Tissue and Rhabdomyosarcoma

ARST0332:  Risk-Based Treatment for Pediatric Non-Rhabdomyosarcoma Soft Tissue Sarcomas

ARST0531:  Randomized Study of Vincristine, Dactinomycin and Cyclophosphamide (VAC) versus VAC Alternating with Vincristine and Irinotecan (VI) for Patients with Intermediate-Risk Rhabdomyosarcoma (RMS)

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

Rare Tumors

ARST0321:  A Phase II Study of Sulindac and Tamoxifen in Patients with Desmoid Tumors that are Recurrent or Not Amenable to Standard Therapy

Osteosarcoma

AOST06B1:  A Children’s Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

AOST0331:  A Randomized Trial of the European and American Osteosarcoma Study Group to Optimize Treatment Strategies for Resectable Osteosarcoma Based on Histological Response to Pre-Operative Chemotherapy

Ewing’s Sarcoma

ADVL0221:  Phase II Study of Trabectedin in Children with Recurrent Rhabdomyosarcoma, Ewing Sarcoma, or Nonrhabdomyosarcoma Soft Tissue Sarcomas

AEWS0521:  A Randomized Phase II Study of Bevacizumab (NSC 704865, BB-IND #7921) Combined with Vincristine, Topotecan and Cyclophosphamide in Patients with First Recurrent Ewing Sarcoma

AEWS07B1:  A Children’s Oncology Group Protocol for Collecting and Banking Ewing Sarcoma Specimens

AEWS0331:  European Ewing Tumor Working Initiative of National Groups, Ewing Tumor Studies 1999

AEWS02B1:  A Group-wide Biology and Banking Study for Ewing Sarcoma

Brain Tumors

ACNS0221:  A Phase II Study of Conformal Radiotherapy in Patients with Low-Grade Gliomas

ACNS0331:  A Study Evaluating Limited Target Volume Boost Irradiation and Reduced Dose Craniospinal Radiotherapy (18.00 Gy) and Chemotherapy in Children with Newly Diagnosed Standard Risk Medulloblastoma:  A Phase III Double Randomized Trial

ACNS02B3:  A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Brain Tumor Research Specimens

ACNS0332:  Efficacy of Carboplatin Administered Concomitantly with Radiation and Isotretinoin as a Pro-Apoptotic Agent in Other Than Average Risk Medulloblastoma/PNET Patients

ACNS0334:  A Phase III Randomized Trial for the Treatment of Newly Diagnosed Supratentorial PNET and High Risk Medulloblastoma in Children < 36 Months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy without Methotrexate

Germ Cell Tumors

AGCT0132:  A Phase III Study of Reduced Therapy in the Treatment of Children with Low and Intermediate Risk Extracranial Germ Cell Tumors

Non-Therapeutic Studies

ADVL06B1:  A Pharmacokinetic-Pharmacodynamic-Pharmacogenetic Study of Actinomycin-D and Vincristine in Children with Cancer

ABTR06C1:  Pharmacokinetics of Daunomycin in Children

ACCRN07:  Childhood Cancer Research Network

4941L:  Wilms’ Tumor Late Effects Study

D9902:  A Group-Wide Protocol for Collecting and Banking Pediatric Cancer Research Specimens

ABTR01B1:  A Children’s Oncology Group Protocol for Collecting and Banking Pediatric Research Specimens Including Rare Pediatric Tumors

ALTE03N1:  Key Adverse Events after Childhood Cancer

ANHL04B1:  Rare and Cutaneous Non-Hodgkin Lymphoma Registry

AEPI04C1:  Low Birth Weight and Other Risk Factors for Hepatoblastoma

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