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.

Condition	Treatment or Intervention	Phase
adult glioblastoma multiforme Quality of Life	Drug: prinomastat  Drug: temozolomide	Phase II

Further Study Details: 

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.

PROTOCOL 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 unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 100 patients will be accrued for this study.

Ages Eligible for Study:  16 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--Patient Characteristics--

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

California
      Agouron Pharmaceuticals, Inc., La Jolla,  California,  92037,  United States

Study chairs or principal investigators

Mary Collier,  Study Chair,  Agouron Pharmaceuticals   

Study ID Numbers:  CDR0000067443; AG-3340-019; MCC-12151; MDA-DM-99254; MSKCC-99116
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 21, 2000
ClinicalTrials.gov Identifier:  NCT00004200
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08