Carmustine in Treating Patients With Recurrent Malignant Glioma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent malignant glioma.

Detailed Description
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OBJECTIVES: Determine the safety of polifeprosan 20 with carmustine implant (GLIADEL) in patients undergoing surgery for recurrent malignant glioma. OUTLINE: This is a dose escalation study. All patients undergo maximal tumor resection. At the time of surgery, groups of 6 patients receive up to 8 polifeprosan 20 wafers containing increasing doses of carmustine implanted into the resection cavity. Patients with an intraoperative diagnosis other than glioblastoma multiforme or anaplastic astrocytoma do not receive wafer implantation, and are removed from study. Patients are followed 3, 6, and 12 months after implantation. PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.

Official Title
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PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: carmustine
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Pathologically confirmed recurrent malignant glioma for which surgery is indicated Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: Creatinine less than 1.5 times normal BUN less than 2.5 times normal Protein no greater than 3 g/dL No gross hematuria Other: No hypersensitivity to nitrosoureas Not pregnant Fertile patients must use effective contraception No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy during first 8 weeks of study Chemotherapy: At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: Not specified Radiotherapy: Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: Prior cytoreductive surgery for supratentorial brain tumor required Biopsy alone not sufficient Other: No concurrent investigational therapy during first 8 weeks of study

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 |
| --- |
|Drug: carmustine|nan|
|Procedure: conventional surgery|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 mixed glioma, recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult ependymoblastoma, adult giant cell glioblastoma, adult gliosarcoma