Overview

Procarbazine and Isotretinoin in Treating Patients With Recurrent Primary Malignant Gliomas

Status:
Withdrawn
Trial end date:
1969-12-31
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. Combining more than one drug may kill more tumor cells. It is not yet known whether giving procarbazine alone or with isotretinoin is more effective for recurrent primary malignant glioma. PURPOSE: Randomized phase III trial to compare the effectiveness of procarbazine alone or with isotretinoin in treating patients with recurrent primary malignant gliomas.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Isotretinoin
Procarbazine
Tretinoin
Criteria
DISEASE CHARACTERISTICS: Histologically proven primary malignant gliomas including the
following: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic
oligodendroglioma Anaplastic infiltrating glioma Mixed malignant gliomas Must show evidence
of tumor recurrence or progression on at least 2 serial enhanced MRI scans Must have
measurably enhancing residual disease on MRI or CT scan of brain

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 8 weeks Hematopoietic: Absolute granulocyte count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times institutional
normal Alkaline phosphatase less than 2 times institutional normal Bilirubin less than 1.5
mg/dL Renal: BUN less than 1.5 times institutional normal OR Creatinine less than 1.5 times
institutional normal Other: No active infection Not pregnant or nursing Fertile patients
must use effective contraception 1 month before, during, and 1 month after study No other
disease that will obscure toxicity or alter drug metabolism No other concurrent medical
illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
procarbazine No prior isotretinoin At least 4 weeks since prior chemotherapy (6 weeks for
nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: Prior
radiotherapy allowed Surgery: Not specified Other: No concurrent tetracyclines