Sarcoma Clinical Trial
Official title:
A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining chemotherapy with peripheral stem cell
transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill
more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus
peripheral stem cell transplantation in treating infants with malignant brain or spinal cord
tumors.
OBJECTIVES:
- Determine the maximum tolerated dose of thiotepa in infants with malignant brain or
spinal cord tumors receiving intensive chemotherapy.
- Determine the feasibility and toxicity of intensive chemotherapy with peripheral blood
stem cell (PBSC) rescue in these patients.
- Assess the feasibility of harvesting PBSCs in these patients.
- Determine the complete response rate and overall event-free survival rate in patients
treated with this regimen.
OUTLINE: This is a pilot, multicenter study.
Patients undergo surgery for diagnosis and maximal tumor resection.
Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising
cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV
over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after
the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and
undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for
up to 3 courses in the absence of disease progression or unacceptable toxicity.
Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy
comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses
of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell
transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on
days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease
progression or unacceptable toxicity.
Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.
Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and
then annually for 3 years or until relapse.
PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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