Motexafin Gadolinium in Treating Patients With Glioblastoma Multiforme Who Are Undergoing Radiation Therapy to the Brain
RATIONALE: 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.
PURPOSE: Phase I trial to study the effectiveness motexafin gadolinium in treating patients with glioblastoma multiforme who are undergoing radiation therapy to the brain.
|Brain and Central Nervous System Tumors||Drug: motexafin gadolinium Radiation: radiation therapy||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme|
|Study Start Date:||April 2002|
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a radiosensitizer in patients with glioblastoma multiforme receiving cranial radiotherapy.
- Determine the maximum tolerated doses of this drug on these 2 schedules in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the biodistribution of this drug in both neoplastic tissue and normal brain parenchyma in these patients.
- Determine the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue in these patients.
- Correlate the effect and accumulation of this drug in both normal brain parenchyma and neoplastic tissue with the pharmacokinetics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120). Patients are sequentially assigned to 1 of 2 treatment groups.
- Group I: Patients receive PCI-0120 IV over 30-60 minutes once every other day for 6 weeks. Patients concurrently undergo cranial radiotherapy once daily 5 days a week for 6 weeks.
- Group II: Patients receive PCI-0120 IV over 30-60 minutes once daily concurrently during radiotherapy. Patients undergo cranial radiotherapy as in group I.
Cohorts of 3-6 patients in each group receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 1 month and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 18-30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032097
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Study Chair:||James L. Pearlman, MD||H. Lee Moffitt Cancer Center and Research Institute|