Clinical Trial: Motexafin Gadolinium and Radiation Therapy in Treating Young Patients With Pontine Glioma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Motexafin-Gadolinium (NSC 695238, IND #55583) and Involved Field Radiation Therapy for Intrinsic Pontine Glioma of Childhood
Brief 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 Summary:
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.
Sponsor: National Cancer Institute (NCI)
Current Primary Outcome: One Year Event-free Survival (EFS) [ Time Frame: Time to disease progression, disease relapse, occurrence of a second neoplasm, or death from any cause, assessed up to 1 year after enrollment. ]
Original Primary Outcome:
Current Secondary Outcome:
- One Year Overall Survival [ Time Frame: Time to death from any cause, assessed up to 1 year after enrollment ]
- Occurrence of Serious Toxicity [ Time Frame: Up to 1 year after enrollment ]Occurrence of serious toxicity defined as any grade 4 hematologic toxicity that persists for more than 7 days or requires platelet transfusions for a time period exceeding 7 days; any grade 3 or 4 non-hematologic toxicity with the exception of grade 3 nausea or vomiting which can be controlled within 7 days; grade 3 skin reaction; grade 3 transaminitis.
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: October 12, 2006
Date Started: June 2007
Date Completion:
Last Updated: May 7, 2014
Last Verified: December 2012
