Prinomastat Plus Temozolomide Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
|ClinicalTrials.gov Identifier: NCT00004200|
Recruitment Status : Completed
First Posted : May 25, 2004
Last Update Posted : August 8, 2012
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: prinomastat Drug: temozolomide||Phase 2|
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.
|Study Type :||Interventional (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|
|Study Start Date :||October 1999|
|Primary Completion Date :||January 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004200
|United States, California|
|Agouron Pharmaceuticals, Inc.|
|La Jolla, California, United States, 92037|
|Study Chair:||Mary Collier||Agouron Pharmaceuticals|