Motexafin Gadolinium Plus Radiation Therapy to the Brain in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as motexafin gadolinium may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase II trial to study the effectiveness of motexafin gadolinium plus radiation therapy to the brain in treating patients who have newly diagnosed glioblastoma multiforme.
|Brain and Central Nervous System Tumors||Drug: motexafin gadolinium Radiation: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||April 2001|
|Study Completion Date:||April 2003|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
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 regimen.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022256
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Josh Yamada, MD||Memorial Sloan Kettering Cancer Center|