Trial Information

Phase II Clinical and Pharmacologic Study of Radiation Therapy and CAI (Carboxy-amido Triazole) in Adults With Newly Diagnosed Glioblastoma Multiforme

OBJECTIVES: I. Determine overall survival rate and duration of disease free progression in
patients with newly diagnosed supratentorial glioblastoma multiforme treated with
carboxyamidotriazole and radiotherapy. II. Evaluate the toxicities of this combination
regimen in this patient population. III. Determine the correlations between pharmacokinetic
parameters and toxicity and/or drug activity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive induction therapy consisting of
radiotherapy once daily 5 days a week plus oral carboxyamidotriazole once daily for 6 weeks
followed by carboxyamidotriazole alone daily for 4 weeks. Patients continue on oral
carboxyamidotriazole once daily as maintenance therapy in the absence of disease progression
or unacceptable toxicity. Patients are followed monthly for survival.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study over 1.5 years.