- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006119
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Bordeaux, France, 33075
- Hopital Saint Andre
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Lyon, France, 69373
- Centre Léon Bérard
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Montpellier, France, 34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Rennes, France, 35042
- Centre Eugène Marquis
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Tours, France, 37044
- Centre Hospitalier Universitaire Bretonneau de Tours
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Didier Frappaz, MD, Centre Léon Bérard
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Nerve Tissue
- Neoplasms, Vascular Tissue
- Meningeal Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Meningioma
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antisickling Agents
- Hydroxyurea
Other Study ID Numbers
- CDR0000068132
- FRE-FNCLCC-98009
- EU-20018
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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