Trials / Completed
CompletedNCT00006119
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- UNICANCER · Academic / Other
- Sex
- All
- Age
- 16 Years – 120 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | hydroxyurea |
Timeline
- Start date
- 1999-07-01
- Primary completion
- 2004-12-01
- Completion
- 2008-01-01
- First posted
- 2003-01-27
- Last updated
- 2021-02-21
Locations
5 sites across 1 country: France
Source: ClinicalTrials.gov record NCT00006119. Inclusion in this directory is not an endorsement.