Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

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 II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.) Determine the qualitative and quantitative toxicity of this regimen in these patients. Assess the activity of this regimen in these patients. Estimate peripheral blood carmustine levels in these patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study. Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy. Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.) Additional patients then receive treatment with DTI-015 at the recommended phase II dose. Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression. PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)

Official Title
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A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme

Conditions
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Brain and Central Nervous System Tumors

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven supratentorial malignant glioblastoma multiforme Clear evidence of disease progression by MRI Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm No brainstem (pons or medulla) or midbrain (mesencephalon) involvement No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve No tumor extension into the ventricular system Tumor volume no greater than 33.4 cm3 At least one prior radiotherapy PATIENT CHARACTERISTICS: Age: 18 to 75 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 No evidence of bleeding diathesis Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT/SGPT no greater than 2.5 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min BUN no greater than 30 mg/dL Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active uncontrolled infection Afebrile unless fever due to presence of tumor No other concurrent serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy and recovered No prior intracranial brachytherapy Surgery: Recovered from any prior surgery Other: No prior anticoagulants No other concurrent investigational agents

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 in ethanol|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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recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma