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Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Clinical research trials and Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma clinical trial. Human subjects often obtain the finest healthcare possible for their Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma  Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
For Condition: localized malignant mesothelioma,advanced malignant mesothelioma,recurrent malignant mesothelioma
Status: No longer recruiting
Sponsor(s): British Thoracic Society , Medical Research Council
Synopsis: RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma. PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.
Details: OBJECTIVES: - Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma. - Determine the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. - Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques). - Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses. - Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14. Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients. Patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Immunohistochemically or cytologically confirmed malignant mesothelioma - Epithelial and other histological types - Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy - Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - WHO 0-2 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,000/mm3 - Neutrophil count greater than 1,500/mm3 - Platelet count greater than 100,000/mm3 Hepatic: - Not specified Renal: - Not specified Other: - Considered medically fit to receive chemotherapy - No other disease or prior malignancy that would preclude study - No clinical evidence of infection PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for mesothelioma Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MartinMuers, Study Chair, Leeds Teaching Hospital Trust
Leeds Teaching Hospital Trust
Leeds, England, LS1 3EX
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
United Kingdom
Royal Marsden Hospital
Sutton, England, SM2 5PT
United Kingdom
Stobhill General Hospital
Glasgow, Scotland, G21 3UW
United Kingdom
St. Peters Hospital
Chertsey Surrey, , KT 16 OPZ
United Kingdom
Dorothy House Foundation
Bradford-Onavon, , BA15 2LE
United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Princess Royal Hospital
Hull, England, HU8 9HE
United Kingdom
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
United Kingdom
Additional Information:
Study ID Numbers: CDR0000069167; EU-20134,BTS-MESO-1,MRC-BTS-MESO-1
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030459
Other Advanced Malignant Mesothelioma Studies:
1. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
2. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
3. Antineoplaston Therapy in Treating Patients With Advanced Mesothelioma
4. Ecteinascidin 743 in Treating Patients With Malignant Mesothelioma
5. Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma
Related Studies:
Other advanced malignant mesothelioma Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
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