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 irinotecan plus carmustine in treating
patients who have recurrent primary malignant glioma.
OBJECTIVES: I. Determine the maximum tolerated dose of irinotecan administered in
combination with a fixed dose of carmustine in patients with recurrent primary malignant
glioma. II. Determine the toxic effects of irinotecan and carmustine in these patients.
OUTLINE: This is a dose escalation study of irinotecan. Patients receive irinotecan IV over
90 minutes weekly on weeks 1-4 and carmustine IV over 1 hour on weeks 1-6. Treatment
continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences
dose limiting toxicities.
PROJECTED ACCRUAL: Approximately 18-36 patients will be accrued for this study.
DISEASE CHARACTERISTICS: Histologically proven recurrent primary malignant glioma
Measurable recurrent or residual primary central nervous system neoplasm confirmed by MRI
PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100%
Hematopoietic: Hematocrit greater than 29% Absolute neutrophil count greater than
1,500/mm3 Platelet count greater than 125,000/mm3 Hepatic: SGOT less than 1.5 times upper
limit of normal (ULN) Bilirubin less than 1.5 times ULN Renal: Creatinine less than 1.5
mg/dL BUN less than 25 mg/dL Pulmonary: DLCO at least 60% Other: Not pregnant Fertile
patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior chemotherapy No prior irinotecan or carmustine treatment failure No more than
1 prior chemotherapy regimen Endocrine therapy: Patients taking corticosteroids must be on
a stable dose for at least 1 week prior to study and the dose should not escalate over
entry dose level Radiotherapy: At least 6 weeks since prior radiotherapy Surgery: At least
3 weeks since prior surgical resection Other: No concurrent medication that may interfere
with study results