Karenitecin 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 karenitecin in treating patients who have recurrent malignant glioma.

Detailed Description
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OBJECTIVES: Determine the maximum tolerated dose of karenitecin in patients with recurrent malignant glioma who are receiving or not receiving anticonvulsants known to be metabolized by the P450 hepatic enzyme complex. Determine the pharmacokinetics of this drug in these patients. Assess the preliminary evidence of therapeutic activity of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs no). Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose associated with a dose-limiting toxicity rate of 33%. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.

Official Title
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Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: karenitecin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme Progressive or recurrent disease previously treated with radiotherapy with or without chemotherapy Prior low-grade disease that progressed to high-grade after therapy allowed Measurable disease by MRI or CT scan 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/mm3 Hemoglobin at least 8.5 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 4 times upper limit of normal Renal: Creatinine no greater than 1.7 mg/dL Other: No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast No serious concurrent infection No other medical illness that would preclude study Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered No more than 1 prior chemotherapy regimen Endocrine therapy: Must be on stable dose of steroids for at least 5 days Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered No more than 1 prior course of radiotherapy Surgery: Not specified Other: No other concurrent investigational agents At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic enzymes

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: karenitecin|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 anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma