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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Randomized Double-Blind, Placebo-Controlled Phase II Study of the Matrix Metalloprotease Inhibitor Prinomastat in Combination With Temozolomide Following Radiation Therapy in Patients Having Newly Diagnosed Glioblastoma Multiforme

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004200
• Other study ID #: AG-3340-019
• Secondary ID: CDR0000067443MCC
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2000
• Last updated: August 7, 2012
• Start date: October 1999

Study information

• Verified date: August 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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 unacceptable toxicity.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioblastoma
• Nervous System Neoplasms

Intervention

Drug:
• prinomastat

• temozolomide

Locations

Country	Name	City	State
United States	Agouron Pharmaceuticals, Inc.	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,