Brain and Central Nervous System Tumors
Conditions
Keywords
adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States