Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT00030459
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2002-02-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D016685', 'term': 'Mitomycin'}, {'id': 'D014747', 'term': 'Vinblastine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D008937', 'term': 'Mitomycins'}, {'id': 'D045563', 'term': 'Indolequinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001389', 'term': 'Azirines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2000-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-05', 'lastUpdateSubmitDate': '2013-08-06', 'studyFirstSubmitDate': '2002-02-14', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['localized malignant mesothelioma', 'advanced malignant mesothelioma', 'recurrent malignant mesothelioma'], 'conditions': ['Malignant Mesothelioma']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine the quality of life of patients treated with these regimens.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.\n\n* Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques).\n* 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.\n* 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.\n\nQuality 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.\n\nPatients are followed every 8 weeks.\n\nPROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Immunohistochemically or cytologically confirmed malignant mesothelioma\n\n * Epithelial and other histological types\n* Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy\n* Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,000/mm3\n* Neutrophil count greater than 1,500/mm3\n* Platelet count greater than 100,000/mm3\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Considered medically fit to receive chemotherapy\n* No other disease or prior malignancy that would preclude study\n* No clinical evidence of infection\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy for mesothelioma\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00030459', 'briefTitle': 'Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma', 'orgStudyIdInfo': {'id': 'BTS-MESO-1'}, 'secondaryIdInfos': [{'id': 'CDR0000069167', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'MRC-BTS-MESO-1'}, {'id': 'EU-20134'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'mitomycin C', 'type': 'DRUG'}, {'name': 'vinblastine sulfate', 'type': 'DRUG'}, {'name': 'vinorelbine tartrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HU8 9HE', 'city': 'Hull', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Princess Royal Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'LS1 3EX', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospital Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'EC1A 7BE', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Saint Bartholomew's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NW1 2DA', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Medical Research Council Clinical Trials Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden Hospital', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}, {'zip': 'G21 3UW', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Stobhill General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'BA15 2LE', 'city': 'Bradford-Onavon', 'country': 'United Kingdom', 'facility': 'Dorothy House Foundation'}, {'zip': 'KT 16 OPZ', 'city': 'Chertsey Surrey', 'country': 'United Kingdom', 'facility': 'St. Peters Hospital'}], 'overallOfficials': [{'name': 'Martin F. Muers, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Leeds General Infirmary'}, {'name': 'David J. Girling, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Research Council'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'British Thoracic Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical Research Council', 'class': 'OTHER_GOV'}]}}}