Expired Study
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Columbus, Ohio 43210


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Histologically confirmed supratentorial glioblastoma multiforme by stereotactic biopsy, open biopsy, or resection - Maximum diameter of the tumor mass must be no greater than 4 cm in any dimension, including following debulking surgery - Tumor must be at least 1.0 cm from the optic chiasm and brainstem - No oligodendrogliomas, meningiomas, or grade I, II, or III astrocytomas - No infratentorial tumors - No multifocal glioblastoma multiforme - Tumor enhances on MRI - Must have visible tumor on postoperative MRI following surgical resection - Performance status - Karnofsky 60-100% - At least 3 months - Hemoglobin at least 10.0 g/dL - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Bilirubin no greater than 1.5 mg/dL - SGPT no greater than 60 U/L - Creatinine no greater than 1.3 mg/dL - Blood urea nitrogen no greater than 24 mg/dL - Neurological function status 0-3 - No evidence of neuropathy - No glucose-6-phosphate dehydrogenase deficiency - No known history of porphyria - History of prior malignancies allowed - HIV positive status allowed - No medical contraindication to MRI imaging (i.e., pacemaker, aneurysm clip, or nonsecure metal fragment close to a critical structure) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception prior to and during study - At least 6 weeks since prior chemotherapy - Concurrent steroids allowed - No prior radiotherapy to the brain or upper neck - No greater than 5 weeks since prior surgery and recovered


NCT ID:

NCT00004262


Primary Contact:

Principal Investigator
John Grecula
Ohio State University


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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