Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients
who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme
following treatment with radiation therapy.
OBJECTIVES:
- Determine the maximum tolerated dose of oral procarbazine when administered to patients
with recurrent glioma receiving or not receiving anticonvulsants metabolized by the
P450 hepatic enzyme complex.
- Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic
enzyme inducing drugs, in these patients.
- Assess the response rate to procarbazine in these patients.
- Evaluate this regimen in terms of overall survival and duration of disease free
survival in these patients.
- Evaluate the toxicity of this regimen in these patients.
OUTLINE: Phase I of this study is a dose escalation study. Patients are stratified according
to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or
modest-induction drugs).
- Phase I: Patients receive oral procarbazine once daily for 5 days. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of oral procarbazine until the maximum
tolerated dose (MTD) is determined.
- Phase II: Once the MTD is determined, patients receive procarbazine as in Phase I.
Patients are followed every 2 months until death.
PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.
;
Primary Purpose: Treatment
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