radiation therapy and gadolinium texaphyrin in treating patients with supratentorial glioblastoma multiforme

Conditions: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma

Summary: 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.

Eligibility 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