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
PURPOSE: Randomized phase II trial to study the effectiveness of prinomastat plus
temozolomide in treating patients who have newly diagnosed glioblastoma multiforme.
OBJECTIVES: I. Compare the one year survival rate and progression free survival of patients
with newly diagnosed glioblastoma multiforme treated with prinomastat (AG3340) or placebo
and temozolomide following radiotherapy. II. Compare the safety of these regimens in these
patients. III. Compare the quality of life in these patients on these regimens.
OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients
receive oral prinomastat or placebo twice daily in combination with oral temozolomide daily
on days 1-5. Treatment repeats every 28 days in the absence of disease progression or
PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.
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
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