Trial Information

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

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.