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.

Condition	Treatment or Intervention	Phase
recurrent adult brain tumor grade III meningioma grade I meningioma grade II meningioma	Drug: hydroxyurea  Procedure: chemotherapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

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

France
      Centre Eugene Marquis, Rennes,  35042,  France
      Centre Hospitalier Universitaire Bretonneau de Tours, Tours,  37044,  France
      Centre Leon Berard, Lyon,  69373,  France
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France
      Hopital Saint Andre, Bordeaux,  33075,  France

Study chairs or principal investigators

Didier Frappaz, MD,  Study Chair,  Centre Leon Berard   

Study ID Numbers:  CDR0000068132; FRE-FNCLCC-98009; EU-20018; NCT00006119
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006119
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08