Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy.
PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation therapy in treating patients who have supratentorial glioblastoma multiforme that has not been previously treated.
Brain and Central Nervous System Tumors
Drug: motexafin gadolinium
Radiation: radiation therapy
|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 Multiforme|
|Study Start Date:||April 1999|
|Study Completion Date:||March 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Evaluate the toxic effects of gadolinium texaphyrin administered to patients receiving cranial radiotherapy for glioblastoma multiforme. II. Determine the maximum tolerated dose of this regimen in these patients. III. Determine the pharmacokinetic profile of this regimen in these patients. IV. Determine the biodistribution of gadolinium texaphyrin in both neoplastic tissue and normal brain parenchyma. V. Evaluate the effect and accumulation of this regimen in normal brain parenchyma and neoplastic tissue by following the change in enhancing volume and percent change in signal intensity over time.
OUTLINE: This is an open label, multicenter study. Arm I: Patients receive radiotherapy once a day, 5 days a week, for 6 weeks. Gadolinium texaphyrin IV is administered every other day within 2-5 hours prior to radiotherapy. Patients are evaluated at 1 month, and if no more than 1 of 3 patients experiences unacceptable toxicity, 3 patients are entered on the imaging portion of the study. Once arm I has successfully entered 3 patients with acceptable toxicity profiles and 3 patients in the imaging portion of the study, patient enrollment begins for arm II. Arm II: Cohorts of 3-9 patients receive radiotherapy as in arm I and escalating doses of gadolinium texaphyrin IV administered within 2-5 hours prior to each radiation dose. The maximum tolerated dose (MTD) of gadolinium texaphyrin is defined as the dose at which no more than one third of the patients experience dose limiting toxicity. Arm III: Patients experiencing dose limiting toxicity in arm II requiring dose reduction below predetermined once a day limit receive gadolinium every other day, with radiotherapy as in arm II. The MTD is defined as in arm II. Arm IV: An additional 3 patients are enrolled at the MTD and enter the imaging portion of the study. Patients are followed for 1 month after final radiation therapy.
PROJECTED ACCRUAL: At least 18 patients will be accrued for this study within 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006452
|Study Chair:||James L. Pearlman, MD||H. Lee Moffitt Cancer Center and Research Institute|