Clinical Trial Finder

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

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.