Overview

Irinotecan Plus Carmustine in Treating Patients With Recurrent Primary Malignant Glioma

Status:
Completed
Trial end date:
2000-11-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Duke University
Collaborator:
National Cancer Institute (NCI)
Treatments:
Camptothecin
Carmustine
Irinotecan
Criteria
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