An Open-Label Phase II Trial to Evaluate the Safety and Pharmacokinetics of Motexafin Gadolinium and Cranial Irradiation in the Treatment of Newly Diagnosed Glioblastoma Multiforme
OBJECTIVES: I. Assess the safety of motexafin gadolinium and cranial irradiation, in terms
of dose-limiting toxicity and clinically significant adverse events, in patients with newly
diagnosed glioblastoma multiforme. II. Evaluate the pharmacokinetics of this regimen in
these patients. III. Determine the survival of patients treated with this regimen. IV.
Assess the activities of daily living and neurological status of patients treated with this
OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 30
minutes on days 1-5 of weeks 1 and 2, and on days 1, 3, and 5 of weeks 3-6. Patients undergo
cranial irradiation on days 1-5 of weeks 1-6. Treatment continues in the absence of disease
progression or unacceptable toxicity. Patients undergo a neurological examination and an
activities of daily living questionnaire at baseline, week 10, and during follow-up visits.
Patients are followed at weeks 10 and 16 and then every 2 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
Josh Yamada, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|