Overview

Biological Therapy in Treating Patients With Glioblastoma Multiforme

Status:
Completed
Trial end date:
1998-07-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase II trial to study the effectiveness of biological therapy in treating patients with glioblastoma multiforme.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Cleveland Clinic
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Sargramostim
Criteria
DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme or anaplastic
astrocytoma Prior surgical resection and radiotherapy completed approximately 1 month prior
to study

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-1 OR Karnofsky 70-100%
Life expectancy: Not specified Hematopoietic: WBC greater than 2000/mm3 Platelet count
greater than 100,000/mm3 Hepatic: No active infection with hepatitis B Renal: Not specified
Other: Not pregnant or nursing Fertile patients must use effective contraception during and
for 1 month after study No active collagen vascular or autoimmune disease No prior severe
reaction to any blood product No other prior malignancy within the past 5 years except
adequately treated squamous cell or basal cell skin cancer, carcinoma in situ or the
cervix, or stage I or II cancer in complete remission Not immunologically compromised due
to chronic conditions Not allergic by standard skin testing HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy with
immunomodulatory effects (e.g., interleukin-2, interferon alfa) Chemotherapy: No prior or
concurrent local or systemic chemotherapy Endocrine therapy: At least 1 week since prior
corticosteroid therapy No concurrent corticosteroid therapy Radiotherapy: See Disease
Characteristics Surgery: See Disease Characteristics Other: No concurrent
antiproliferatives or immunosuppressants