Overview

Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

Status:
Completed
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of cladribine followed by radiation therapy in treating patients who have malignant glioma.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Institute (NCI)
Treatments:
Cladribine
Criteria
DISEASE CHARACTERISTICS: Histologically proven high-grade glioma confined to 1 or both
hemispheres of the brain and including: Grade III astrocytoma (anaplastic astrocytoma)
Grade IV astrocytoma (glioblastoma multiforme) ineligible for NCI-95-C-0069 protocol
Histologic confirmation of high-grade astrocytoma by NIH neuropathology division required
(including mandatory review of slides from biopsy or resection) No evidence of metastatic
or leptomeningeal spread

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% ECOG 0-2 Life
expectancy: Greater than 6 months Hematopoietic: WBC at least 3,500/mm3 Absolute
granulocyte count at least 900/mm3 Absolute leukocyte count at least 900/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Liver function tests no greater
than 2.5 times upper limit of normal Renal: Creatinine clearance at least 95 mL/min
Creatinine no greater than 1.3 mg/dL Other: No history of psychiatric disease that would
prevent compliance No other malignancy within the past 5 years except: Basal cell carcinoma
of the skin Carcinoma in situ of the cervix Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No systemic
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior cranial radiotherapy
Surgery: No more than 3 months since surgery (biopsy; subtotal or near-total resection)