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Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma Clinical research trials and Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma. Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma  Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
For Condition: adult malignant meningioma,recurrent adult brain tumor
Status: Recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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 unresectablemeningioma.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DidierFrappaz, Study Chair, Centre Leon Berard
Centre Leon Berard *Recruiting*
Lyon, , 69373
France
Recruiting Yves Devaux 33-04-78-782-645
Hopital Saint Andre *Recruiting*
Bordeaux, , 33075
France
Recruiting Jean-Philippe Maire 05-56-79-58-08
Centre Hospitalier Universitaire Bretonneau de Tours *Recruiting*
Tours, , 37044
France
Recruiting C. Linassier 02-47-47-80-76
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle *Recruiting*
Montpellier, , 34298
France
Recruiting Michel Fabbro 04-67-61-30-63
Centre Eugene Marquis *Recruiting*
Rennes, , 35042
France
Recruiting Thierry Lesimple 33-011-33-99-253-195
Additional Information:
Study ID Numbers: CDR0000068132; FRE-FNCLCC-98009,EU-20018
Study Start Date:
Record last reviewed: August 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006119
Other Adult Malignant Meningioma Studies:
1. COL-3 in Treating Patients With Progressive or Recurrent Brain Tumors
2. Temozolomide and O6-benzylguanine in Treating Patients With Newly Diagnosed, Recurrent, or Progressive Anaplastic Glioma
3. Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
4. O6-benzylguanine and Carmustine Implants in Treating Patients With Recurrent Malignant Glioma
5. Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Related Studies:
Other adult malignant meningioma Clinical Trials
Other Clinical Trials
Other Rennes Clinical Trials
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
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