Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

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 hydroxyurea in treating patients who have recurrent and/or unresectable meningioma.

Detailed Description
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OBJECTIVES: Determine complete, partial, or stable response to hydroxyurea in patients with recurrent and/or nonresectable meningioma. Determine response at 2 years to this regimen in these patients. Determine overall and disease free survival of these patients after this regimen. Determine quality of life of these patients. Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease (I vs II or III). Patients receive oral hydroxyurea daily for 2 years. Quality of life is assessed before treatment, then every 3 months for 2 years. PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.

Official Title
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Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma

Conditions
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Brain and Central Nervous System Tumors

Intervention / Treatment
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* Drug: hydroxyurea


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven progressive meningioma that is not curable by surgery PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 70-100% Life expectancy: Over 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST and ALT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 6 months after study No other malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Concurrent corticosteroids allowed for control of intracranial pressure Radiotherapy: Prior radiotherapy allowed No concurrent radiotherapy Surgery: See Disease Characteristics Other: At least 1 year since prior experimental therapy

Ages Eligible for Study
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Minimum Age: 16 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: hydroxyurea|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 grade III meningioma, adult grade I meningioma, adult grade II meningioma