Overview

Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Prinomastat may stop the growth of glioblastoma multiforme by stopping blood flow to the tumor. Drugs used in chemotherapy stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Dacarbazine
Prinomastat
Temozolomide
Criteria
DISEASE CHARACTERISTICS: Newly diagnosed glioblastoma multiforme Must have completed all
appropriate subtotal or total surgical procedures (surgical biopsy alone not eligible) Must
have received prior external beam radiotherapy No multifocal glioblastoma multiforme No
radiographic disease progression during post surgical radiotherapy

PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not
specified

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Stable steroid therapy for at least 2 weeks prior to study Radiotherapy:
See Disease Characteristics No prior interstitial brachytherapy or radiosurgery Surgery:
See Disease Characteristics No prior radiosurgery