Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

UNICANCER

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Brain and Central Nervous System Tumors

Interventions

hydroxyureaDRUG

Eligibility

Sex: ALLMin age: 16 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (5)

Hopital Saint Andre

Bordeaux, France

Centre Leon Berard

Lyon, France

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, France

Centre Eugene Marquis

Rennes, France

Data from ClinicalTrials.gov

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