surgery followed by radiation therapy in treating patients with newly diagnosed glioblastoma multiforme

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. external-beam radiation therapy uses high-energy x-rays to kill tumor cells. combining internal radiation with external-beam radiation therapy may kill any remaining tumor cells following surgery. purpose: phase i trial to study the effectiveness of combining internal radiation therapy with external-beam radiation therapy in treating patients who have undergone surgery for glioblastoma multiforme.

objectives: * determine the maximum tolerated dose of brachytherapy administered via gliasite rts™ applicator followed by external beam radiotherapy in patients with newly diagnosed glioblastoma multiforme. * determine the acute and chronic toxicity of brachytherapy administered via gliasite rts™ in these patients. * determine the survival rate of patients treated with this regimen. outline: this is a multicenter, dose-escalation study of brachytherapy. patients undergo craniotomy for histologic confirmation of glioblastoma multiforme, surgical resection, and placement of a gliasite rts™ applicator that includes iotrex™. beginning 3-21 days after surgery, patients undergo brachytherapy via the gliasite rts™ applicator. within 30 days of brachytherapy (no more than 60 days after resection) patients undergo external beam radiotherapy 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 5-10 patients receive escalating doses of brachytherapy until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 5 or 3 of 10 patients experience dose-limiting toxicity. patients are followed at 21-35 days, every 2 months for 1 year, and then for survival. projected accrual: a total of 15-100 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * clinically suspected supratentorial grade iv glioblastoma multiforme * candidate for maximal surgical resection of tumor mass * expected residual enhancing tumor must be within the expected brachytherapy treatment volume * resection must not be expected to result in a new permanent neurologic deficit * no clearly multi-focal disease (2 or more separate foci of contrast-enhancing tumor not all within the expected brachytherapy prescription volume by mri) * no enhancing tumor greater than 1 cm beyond the midline by mri * no grossly or radiographically apparent leptomeningeal spread and/or ventricular invasion outside the anticipated radiation treatment volume * no marked edema by mri with significant shift that is not anticipated to be corrected by resection patient characteristics: age * 18 and over performance status * karnofsky 60-100% life expectancy * not specified hematopoietic * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic * not specified renal * creatinine no greater than 1.7 mg/dl * bun no greater than 2 times upper limit of normal cardiovascular * no uncontrolled hypertension * no unstable angina pectoris * no uncontrolled cardiac dysrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * mini mental state exam score at least 15 * no other concurrent medical illness that would preclude study participation * no concurrent serious infection * no other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer prior concurrent therapy: biologic therapy * no immunotherapy prior to, during, or within 90 days after brachytherapy * no biologic therapy with any of the following prior to, during, or within 90 days after brachytherapy : * immunotoxins * immunoconjugates * antiangiogenesis compounds * peptide receptor antagonists * interferons * interleukins * tumor-infiltrating lymphocytes * lymphokine-activated killer cells * gene therapy * antisense agents chemotherapy * no chemotherapy or polifeprosan 20 with carmustine implant (gliadel wafers) prior to, during, or within 90 days after brachytherapy endocrine therapy * no hormonal therapy prior to, during, or within 90 days after brachytherapy * concurrent corticosteroids to improve quality of life allowed radiotherapy * no other radiotherapy prior to, during, or within 90 days after brachytherapy surgery * see disease characteristics * no radiosurgery prior to, during, or within 90 days after brachytherapy other * no other investigational agents directed at the brain tumor prior to, during, or within 90 days after brachytherapy * concurrent noncytotoxic therapy to improve quality of life allowed

Keywords: adult glioblastoma adult giant cell glioblastoma adult gliosarcoma