Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
UNICANCER
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006119
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: December 2004
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: hydroxyurea |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Study of Hydroxyurea for the Treatment of Recurrent and/or Nonoperable Meningioma |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | July 1999 |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006119
Locations
| France | |
| 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 | |
Sponsors and Collaborators
UNICANCER
Investigators
| Study Chair: | Didier Frappaz, MD | Centre Leon Berard |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006119 History of Changes |
| Other Study ID Numbers: | CDR0000068132, FRE-FNCLCC-98009, EU-20018 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult grade III meningioma adult grade I meningioma adult grade II meningioma |
Additional relevant MeSH terms:
|
Meningioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue Meningeal Neoplasms Neoplasms by Site Nervous System Diseases |
Hydroxyurea Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antisickling Agents Hematologic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013