Brain and Central Nervous System Tumors Clinical Trial
Official title:
Phase I Treatment of Adults With Primary Malignant Glioma With Topotecan (NSC #609699) Plus BCNU (NSC #409962)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of topotecan plus carmustine in patients
with recurrent primary malignant glioma.
OBJECTIVES:
- Determine the maximum tolerated dose of topotecan administered in combination with a
fixed dose of carmustine.
- Determine the toxic effects of topotecan and carmustine in patients with recurrent
primary malignant glioma.
OUTLINE: Topotecan is administered by an ambulatory infusion pump for 72 hours each week.
Topotecan dose escalation is carried out in cohorts of three patients. Dose escalation is
continued until toxic effects or disease progression is observed in these patients.
Carmustine is administered over 1 hour every 6 weeks, on the same day as the first topotecan
dose for that week.
Three patients will be treated at an initial dose level of topotecan, and if one of these
patients experience dose limiting toxicity (DLT), an additional
3 patients must be treated at this dose level without further DLT in order for dose
escalation to proceed. The MTD is the highest dose at which DLT occurs in no more than 1 of
6 patients.
Patients are evaluated after every 6 week cycle.
PROJECTED ACCRUAL: An estimated 18-36 patients will be entered.
;
Primary Purpose: Treatment
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