Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 2:23 PM
Study NCT ID:
NCT00908869
Status:
COMPLETED
Last Update Posted:
2012-01-30
First Post:
2009-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b (" Metronomic Chemotherapy ") for Antiangiogenic and Antivascular Effect. Trial With Pharmacodynamic Study in Adult Advanced Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077190', 'term': 'Interferon alpha-2'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D007370', 'term': 'Interferon Type I'}, {'id': 'D007372', 'term': 'Interferons'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-26', 'studyFirstSubmitDate': '2009-05-25', 'studyFirstSubmitQcDate': '2009-05-26', 'lastUpdatePostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Estimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['advanced neoplasm', 'adult advanced neoplasm'], 'conditions': ['Advanced Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr/', 'label': 'official site of the sponsor'}]}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nThis phase I trial estimates the antiangiogenic and antivascular effect of 4 different levels of continuous low doses of the combination of Vinorelbine, Cyclophosphamide and Interferon alpha 2b (" metronomic chemotherapy ")in adult advanced neoplasm.\n\nThis study is non randomized, monocentric, and with a pharmacodynamic part.\n\nPrimary objective:\n\nEstimation of the toxicity of the combination of continuous low doses of Vinorelbine, Cyclophosphamide and Interferon alpha 2b.\n\nSecondary objectives:\n\nEstimation of the antiangiogenic and/or antivascular effect (VEGF measurement) in radiography (DEC-MRI), biology and immunohistochemistry of the treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged from 18 and older,\n* with metastatic or advanced solid tumor who received all standard treatments,\n* who ended their chemotherapy or radiotherapy treatment within 4 weeks (6 weeks for mitocyne)prior entry in the study.\n* All patients are included after being given written informed consent.\n\nExclusion Criteria:\n\n* patients with stable disease,\n* history or presence of another cancer,\n* contraindication to administer the treatment,\n* contraindication to perform MRI,\n* pregnancy or breast feeding.'}, 'identificationModule': {'nctId': 'NCT00908869', 'acronym': 'METRO1', 'briefTitle': 'Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b (" Metronomic Chemotherapy ") for Antiangiogenic and Antivascular Effect. Trial With Pharmacodynamic Study in Adult Advanced Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm', 'orgStudyIdInfo': {'id': 'METRO1/IPC2005-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Vinorelbine, Cyclophosphamide and Interferon alpha 2b', 'type': 'DRUG', 'description': 'Level 1: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.\n\nLevel 2: Oral Vinorelbine (Navelbine®)20mg x 3/week; oral Cyclophosphamide (Endoxan®) 50mg/day;SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week.\n\nLevel 3: Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/day; SC interferon alpha 2b (Introna®) 0.9 million IU x 5/week.\n\nLevel -1 (in case of toxicity at level 1): Oral Vinorelbine (Navelbine®)20mg x 2/week; oral Cyclophosphamide (Endoxan®) 50mg/every 2 days; SC interferon alpha 2b (Introna®) 0.9 million IU x 3/week .'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13008', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Anthony GONCALVES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}