Brachytherapy in Treating Patients With Recurrent Malignant Glioma

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Brachytherapy Dose Escalating Study Using the Proxima Therapeutics, Inc. GliaSite RTS in Patients With Recurrent Malignant Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Procedure: adjuvant therapy
* Radiation: iodine I 125


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|nan|
|Radiation: iodine I 125|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma