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Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Clinical research trials and Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors. Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors clinical trial. Participants frequently get the best healthcare available for their Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors  Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
For Condition: Adult Oligodendroglioma,Mixed Gliomas
Status: No longer recruiting
Sponsor(s): EORTC Brain Tumor Cooperative Group ,
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 temozolomide in treating patients with recurrent oligodendroglial tumors.
Details: OBJECTIVES: I. Assess the therapeutic activity of temozolomide as first line chemotherapy in patients with recurrent oligodendroglial tumors after radiation therapy. II. Assess the objective response and duration of response of these patients given this treatment. III. Characterize the acute side effects of temozolomide in this patient population. PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive oral temozolomide on days 1-5. Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/70 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven oligodendroglioma or oligoastrocytoma with at least 25% oligodendroglial elements - Recurrent or progressive disease following radiotherapy; At least 3 months since prior radiotherapy - Measurable disease by MRI or CT scan Lesion must have a diameter of at least 1 cm - No progressive neurological deficits from the present recurrence - No new neurological deficits interfering with daily activities - No tumor causing midline shift or brain stem compression due to which a rapid deterioration is to be expected in case of no response - No signs of increased intracranial pressure - No extracranial disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: Not specified - Other: No other concurrent investigational drugs; No other concurrent antitumor agents --Patient Characteristics-- - Age: 18 to 70 - Performance status: WHO 0-2 - Life expectancy: At least 3 months - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN); AST/ALT no greater than 2 times ULN; Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine clearance at least 60 mL/min; Creatinine no greater than 1.25 times ULN - Neurologic: See Disease Characteristics - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other malignant or nonmalignant diseases interfering with follow-up; No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study and follow-up
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Martinvan Den Bent, Study Chair, EORTC Brain Tumor Cooperative Group
Centre Antoine Lacassagne
Nice, , 06189
France
CHU de la Timone
Marseille, , 13385
France
Istituti Fisioterapici Ospitalieri - Roma
Rome, , 00161
Italy
CHU de Nancy - Hopital Neurologique
Nancy, , 54035
France
University Hospital
Basel, , CH-4031
Switzerland
Rotterdam Cancer Institute
Rotterdam, , 3075 EA
Netherlands
Universitaetsklinikum Benjamin Franklin
Berlin, , D-12200
Germany
Hopital Universitaire Erasme
Brussels, , 1070
Belgium
Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , 1090
Belgium
University Medical Center Nijmegen
Nijmegen, , NL-6252 HB
Netherlands
Kantonspital Aarau
AARAU, , 5001
Switzerland
Academisch Ziekenhuis Utrecht
Utrecht, , 3508 GA
Netherlands
Klinikum der Universitat Regensburg
Regensburg, , DOH-9-3053
Germany
Western General Hospital
Edinburgh, Scotland, EH4 9NQ
United Kingdom
Centre Hospitalier Regional de Lille
Lille, , 59037
France
U.Z. Gasthuisberg
Leuven, , B-3000
Belgium
Postgraduate Medical Institute
Bratislava, , 833 03
Slovakia
Inselspital, Bern
Bern, , CH-3010
Switzerland
Instituto Portugues de Oncologia de Francisco Gentil
Lisbon, , 1093
Portugal
Centre Hospitalier Universitaire Vaudois
Lausanne, , CH-1011
Switzerland
Nervenklinik Bamberg
Bamberg, , D-96049
Germany
Hopital Pasteur
Nice, , 06002
France
Institut Gustave Roussy
Villejuif, , F-94805
France
Azienda Ospedaliera di Padova
Padova (Padua), , 35128
Italy
Additional Information:
Study ID Numbers: CDR0000066846; EORTC-26971
Study Start Date: December 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003731
Other Mixed Gliomas Studies:
1. Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma
2. Lonafarnib and Temozolomide in Treating Patients With Recurrent Primary Supratentorial Gliomas
3. Pyrazoloacridine Plus Carboplatin in Treating Patients With Recurrent Glioma
4. Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma
5. Irinotecan in Treating Patients With Progressive or Recurrent Malignant Glioma
Related Studies:
Other Mixed Gliomas Clinical Trials
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Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
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