Adult Glioblastoma Clinical Trial
Official title:
PHASE I TRIAL OF GADOLINIUM TEXAPHYRIN (PCI -0120) AS A RADIOSENSITIZER DURING STEREOTACTIC RADIOSURGERY BOOST FOR GLIOBLASTOMA MULTIFORME
Phase I trial to study the effectiveness of radiation therapy and gadolinium texaphyrin in treating patients who have supratentorial glioblastoma multiforme. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy.
PRIMARY OBJECTIVES:
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
death.
PROJECTED ACCRUAL: Approximately 12-18 patients will be accrued for this study within 12-18
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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