Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Trial of BCNU Plus O6-Benzylguanine in the Treatment of Patients With Recurrent, Persistent or Progressive Cerebral Anaplastic Gliomas
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of carmustine plus O(6)-benzylguanine in
treating patients who have recurrent or progressive gliomas of the brain.
OBJECTIVES: I. Determine the maximum tolerated dose of carmustine when administered
following O6-benzylguanine in patients with recurrent, persistent, or progressive cerebral
anaplastic gliomas. II. Characterize the toxic effects associated with this treatment
regimen in these patients. III. Observe patients for clinical antitumor response when
treated with this regimen.
OUTLINE: Patients are stratified according to prior nitrosourea administration (yes or no).
(Prior nitrosoureas stratum closed) An initial cohort of 3 patients per stratum is treated
with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous
carmustine every 6 weeks. Additional cohorts of 3-6 patients are treated with escalating
doses of carmustine until dose limiting toxicity (DLT) is observed. The maximum tolerated
dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Courses
are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 24-56 patients (12-28 per stratum) will be accrued in 12
months.
;
Primary Purpose: Treatment
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