Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

Study Overview
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Brief Summary
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RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.

Detailed Description
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OBJECTIVES: Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in patients with recurrent or poor prognosis grade 4 astrocytoma. Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients. Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients. Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients. OUTLINE: This is a dose-escalation study. Patients receive interstitial colloidal phosphorus P32 (C P32) on day 0. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose (MTD) is determined. The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed at 1, 2, 4, 6, 9, 15, and 24 weeks. PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.

Official Title
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Phase I/II Study of Interstitial Colloidal 32P for the Treatment of Recurrent Malignant Central Nervous System Tumors and Primary Central Nervous System Tumors With Poor Prognostic Factors

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Radiation: brachytherapy
* Radiation: phosphorus P32


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven grade 4 astrocytoma (glioblastoma) Failed external beam radiotherapy and/or surgery OR Poor prognosis disease No clinical evidence of metastatic disease within the CNS other than the primary tumor site Stereotactic biopsy or gross total excision with residual tumor Lesion 3 to 5 cm in size No spinal cord tumor(s) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Neutrophil count at least 1,900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic: Not specified Renal: Creatinine no greater than 1.5 mg/dL BUN less than 25 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

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 |
| --- |
|Radiation: brachytherapy|nan|
|Radiation: phosphorus P32|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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recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma