SarCNU 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 II trial to study the effectiveness of sarCNU in treating patients who have recurrent malignant glioma.

Detailed Description
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OBJECTIVES: Determine the efficacy of SarCNU, in terms of objective response and duration of response, in patients with recurrent malignant gliomas. Determine the qualitative and quantitative toxic effects of this drug in these patients. Determine the time to progression and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18 months.

Official Title
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A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: SarCNU


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma Anaplastic astrocytoma (AA) OR Glioblastoma multiforme (GBM) Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy At least 1 bidimensionally measurable lesion At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin normal AST and ALT no greater than 2.5 times upper limit of normal Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Pulmonary: DLCO at least 70% of predicted FVC at least 70% of predicted Other: No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix No ongoing or active uncontrolled infection No other serious illness or medical condition that would preclude study No history of significant neurologic or psychiatric disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: At least 6 weeks since prior chemotherapy No more than 1 prior adjuvant chemotherapy regimen for AA No prior chemotherapy for recurrent disease No other concurrent chemotherapy Endocrine therapy: Patients must be on a stable dose of steroids for at least 2 weeks prior to study Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy for recurrent disease No concurrent radiotherapy Surgery: See Disease Characteristics Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed At least 4 weeks since prior surgery (except for biopsy) Other: At least 6 weeks since prior investigational agents No other concurrent investigational agents No other concurrent anticancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SarCNU|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 giant cell glioblastoma, adult gliosarcoma