Motexafin Gadolinium Plus Radiation Therapy in Treating Children With Newly Diagnosed Brain Stem Glioma

Overview

Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make the tumor cells more sensitive to radiation therapy. Phase I trial to study the effectiveness of motexafin gadolinium plus radiation therapy in treating children who have newly diagnosed brain stem glioma

OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic pontine glioma. II. Determine the toxic effects of this drug given at the MTD in these patients. III. Determine the intratumor and brain distribution of this drug by magnetic resonance imaging (MRI) in these patients. OUTLINE: This is a dose-escalation study of motexafin gadolinium. Approximately 2-5 hours before radiotherapy, patients receive motexafin gadolinium IV over 5 minutes. Patients undergo radiotherapy 5 days a week for 6 weeks. Cohorts of 3-6 patients receive escalating doses of motexafin gadolinium until the MTD is determined. The first cohort receives motexafin gadolinium 5 days a week for 3 weeks; the second cohort receives motexafin gadolinium 3 days a week for 6 weeks; and subsequent cohorts receive motexafin gadolinium 5 days a week for 6 weeks. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for up to 3 years. PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study within 2 years.

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