A Phase I Study of Motexafin Gadolinium (Xcytrin, NSC 695238) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
I. Determine the maximum tolerated dose (MTD) and schedule of motexafin gadolinium
administered prior to radiotherapy in children with newly diagnosed diffuse intrinsic
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD defined as the dose at which fewer than one-third of patients experience DLT assessed using CTC version 2.0
Children's Oncology Group
United States: Food and Drug Administration
|Children's Oncology Group||Arcadia, California 91006-3776|