PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
I. Determine the frequency and grade of toxicity of gadolinium texaphyrin as a
radiosensitizer at two dose levels in patients with supratentorial glioblastoma multiforme
undergoing stereotactic radiosurgery.
II. Compare the tumor, normal brain, and plasma concentrations of this drug regimen to 1.5
and 8 Tesla MRI images in this patient population.
III. Determine if the 8 Tesla images provide more data than the 1.5 Tesla images in terms of
the radiosensitizing drug distribution in the tumor in these patients.
OUTLINE: This is a dose escalation study.
Within 5 weeks following surgery, patients receive daily external beam radiotherapy five
days a week for 5 weeks. Within 2 weeks following completion of radiotherapy, patients
receive gadolinium texaphyrin IV over 2 hours followed 3 hours later by stereotactic
radiosurgery. Patients undergoing surgical debulking of tumor prior to external beam
radiotherapy receive gadolinium texaphyrin IV over 2 hours, 3 hours prior to surgery in
addition to the dose prior to stereotactic radiosurgery.
Cohorts of 3-6 patients receive escalating doses of gadolinium texaphyrin until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 or 2 of 6 patients experience dose limiting toxicity.
Patients are followed monthly for 3 months, and then every 3 months for 5 years or until
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) based on the incidence of dose-limiting toxicity (DLT), as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
At the time of stereotactic radiosurgery
Ohio State University
United States: Food and Drug Administration
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|