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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002594 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so that they stop growing or die. bone marrow transplantation and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: cyclophosphamide Drug: melphalan Drug: sargramostim Procedure: autologous bone marrow transplantation Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY |
Estimated Enrollment: | 30 |
Study Start Date: | September 1994 |
OBJECTIVES:
OUTLINE: Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover.
Patients are followed every 6 months through year 4 and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.
Ages Eligible for Study: | 2 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of recurrent medulloblastoma or CNS germ cell tumor
Histologic review of the primary intracranial or spinal cord tumor required
No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Donald H. Mahoney, MD | Texas Children's Cancer Center |
Study ID Numbers: | CDR0000063784, COG-P9430, POG-9430 |
Study First Received: | November 1, 1999 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00002594 |
Health Authority: | United States: Federal Government |
recurrent childhood brain tumor childhood central nervous system germ cell tumor recurrent childhood medulloblastoma |
Melphalan Neuroectodermal Tumors, Primitive Central Nervous System Neoplasms Cyclophosphamide Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Medulloblastoma Neuroepithelioma Glioma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Antirheumatic Agents Alkylating Agents |