Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 16 and over | Other | FRE-FNCLCC-98009 EU-20018, NCT00006119 |
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.
Entry Criteria
Disease Characteristics:
- Histologically proven progressive meningioma that is not curable by surgery
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
Patient Characteristics:
Age:
- 16 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Over 3 months
Hematopoietic:
- WBC at least 3,000/mm3
- Platelet count at least 100,000/mm3
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
Expected Enrollment
A total of 60 patients (30 per stratum) will be accrued for this study.
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.
Trial Lead Organizations
Federation Nationale des Centres de Lutte Contre le Cancer
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| Didier Frappaz, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma | |
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| Trial Start Date | 1999-07-15 | |
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| Registered in ClinicalTrials.gov | NCT00006119 | |
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| Date Submitted to PDQ | 2000-07-05 | |
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| Information Last Verified | 2004-12-02 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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