Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006119

Enrollment

Unknown

Registered

2003-01-27

Start date

1999-07-31

Completion date

2008-01-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor, adult grade III meningioma, adult grade I meningioma, adult grade II meningioma

Brief 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.

Detailed 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.

Interventions

DRUGhydroxyurea

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

16 Years to 120 Years

Healthy volunteers

Inclusion 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026