NCT00387790

Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma

A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well giving motexafin gadolinium together with radiation therapy works in treating young patients with pontine glioma. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as motexafin gadolinium, may make tumor cells more sensitive to radiation therapy. Giving motexafin gadolinium together with radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year event-free survival of pediatric patients with intrinsic pontine glioma (brain stem glioma). SECONDARY OBJECTIVES: I. Evaluate the effect of combining motexafin gadolinium with daily fractionated radiotherapy on 1-year overall survival of these patients. II. Determine the toxicities of motexafin gadolinium in combination with radiotherapy in these patients. OUTLINE: This is a multicenter study. Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo focal cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 3 years and then periodically thereafter.

Conditions

• Untreated Childhood Brain Stem Glioma

Interventions

Type	Name	Description
DRUG	motexafin gadolinium	Given IV
RADIATION	3-dimensional conformal radiation therapy	Undergo focal cranial radiotherapy

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2006-10-13
• Last updated: 2018-01-04
• Results posted: 2014-02-05

Locations

1 site across 1 country: United States