Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
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|ClinicalTrials.gov Identifier: NCT00006119|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 21, 2021
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 or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Drug: hydroxyurea||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma|
|Actual Study Start Date :||July 1999|
|Actual Primary Completion Date :||December 2004|
|Actual Study Completion Date :||January 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006119
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Centre Leon Berard|
|Lyon, France, 69373|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Eugene Marquis|
|Rennes, France, 35042|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Study Chair:||Didier Frappaz, MD||Centre Leon Berard|