Overview

This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatment hydroxyurea
Phase phase 2
Sponsor UNICANCER
Start date July 1999
Trial identifier NCT00006119, CDR0000068132, EU-20018, FRE-FNCLCC-98009

Summary

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

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).