Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
This trial is active, not recruiting.
|Condition||brain and central nervous system tumors|
|Start date||July 1999|
|Trial identifier||NCT00006119, CDR0000068132, EU-20018, FRE-FNCLCC-98009|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Bordeaux, France||Hopital Saint Andre||no longer recruiting|
|Lyon, France||Centre Leon Berard||no longer recruiting|
|Montpellier, France||Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle||no longer recruiting|
|Rennes, France||Centre Eugene Marquis||no longer recruiting|
|Tours, France||Centre Hospitalier Universitaire Bretonneau de Tours||no longer recruiting|
Male or female participants at least 16 years old.
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
|Official title||Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma|
|Description||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.|
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