Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
OBJECTIVES: * 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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
