brachytherapy in treating patients with recurrent malignant glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: brachytherapy uses radioactive material to kill cancer cells remaining after surgery. purpose: phase i trial to study the effectiveness of brachytherapy in treating patients who have recurrent malignant glioma.

objectives: * determine the maximum tolerated dose of brachytherapy using an intracavitary applicator and liquid iodine i 125 in patients with recurrent malignant glioma. * determine the acute and chronic toxicity of this therapy in these patients. outline: this is a dose-escalation, multicenter study. within 3-21 days after surgical resection, patients receive brachytherapy using an intracavity balloon application (gliasite) with iodine i 125 solution for a total of 5-7 days. 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 10 patients experience dose-limiting toxicity. patients are followed at 4 weeks and then every 2 months for 1 year. projected accrual: approximately 20-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed malignant glioma * anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme * low-grade astrocytoma that progresses to high-grade astrocytoma allowed * unifocal disease * progressive or recurrent after radiotherapy with or without chemotherapy * previously treated with at least 5,000 cgy external beam radiotherapy more than 3 months ago * candidate for maximal surgical resection * any expected residual enhancing tumor must be within expected brachytherapy treatment volume * resection must not be expected to result in a new permanent neurologic deficit * no tumor crossing more than 1 cm beyond the midline on preoperative mri or ct scan * no grossly or radiographically apparent leptomeningeal spread * no ventricular invasion outside the anticipated radiotherapy treatment volume * no marked edema on mri or ct scan * patients with 2 or more separate foci of contrast-enhancing tumors that are more than 5 cm apart on preoperative mri or ct scan are ineligible 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 * mini mental score at least 15 * no other medical illness that would preclude study participation * no serious infection * no other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * not pregnant or nursing * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * no concurrent immunotherapy * no concurrent biologic agents (e.g., immunotoxins, immunoconjugates, antiangiogenesis compounds, antisense therapy, peptide receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphokine-activated killer cells, or gene therapy) chemotherapy * see disease characteristics * at least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) * no concurrent polifeprosan 20 with carmustine implant (gliadel wafer) endocrine therapy * concurrent corticosteroids allowed to improve quality of life radiotherapy * see disease characteristics * no concurrent radiosurgery surgery * see disease characteristics * see radiotherapy other * recovered from prior therapy * no prior investigational agents * no investigational agents during and for 90 days after study participation * concurrent cytotoxic treatment allowed to improve quality of life

Keywords: adult anaplastic astrocytoma adult anaplastic oligodendroglioma adult glioblastoma recurrent adult brain tumor adult giant cell glioblastoma adult gliosarcoma