A Phase I Trial To Evaluate Repetitive Intravenous Doses Of Gadolinium-Texaphyrin As A Radiosensitizer In Patients With Glioblastoma Multi Forme
- Determine the toxicity of 2 different schedules of motexafin gadolinium as a
radiosensitizer in patients with glioblastoma multiforme receiving cranial
- Determine the maximum tolerated doses of this drug on these 2 schedules in these
- 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
- 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.
Primary Purpose: Treatment
James L. Pearlman, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|