Brain Tumor Clinical Trial
Official title:
Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
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.
OBJECTIVES:
- Determine the response and progression-free survival in patients with recurrent
medulloblastoma or CNS germ cell tumors treated with intensive melphalan and
cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell
rescue.
- Determine the acute and delayed toxic effects of this regimen in these patients.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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