Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-25 @ 5:17 PM
Study NCT ID:
NCT00630903
Status:
TERMINATED
Last Update Posted:
2008-03-07
First Post:
2008-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009182', 'term': 'Mycosis Fungoides'}], 'ancestors': [{'id': 'D016410', 'term': 'Lymphoma, T-Cell, Cutaneous'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008730', 'term': 'Methoxsalen'}], 'ancestors': [{'id': 'D011564', 'term': 'Furocoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'Insufficient accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'lastUpdateSubmitDate': '2008-03-06', 'studyFirstSubmitDate': '2008-02-28', 'studyFirstSubmitQcDate': '2008-03-06', 'lastUpdatePostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of PUVA vs PUVA + IFN', 'timeFrame': 'Weeks 4, 8, 12, 16 and 24'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cutaneous T-Cell Lymphoma (Mycosis Fungoides)']}, 'referencesModule': {'references': [{'pmid': '32632956', 'type': 'DERIVED', 'citation': 'Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if combination of PUVA with interferon alpha is better than PUVA alone to treat mycosis fungoides stage Ia Ib or IIa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mycosis fungoides Stage Ia Ib IIa\n* Written informed consent\n* 18-70 y.o., both sex\n* No concomitant systemic disease\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Fertile women not accepting contraception\n* Medical history of melanoma or non melanoma skin cancer\n* Concomitant infections\n* Immunodeficiency states\n* Previous Heart disease\n* Respiratory insufficiency\n* Chronic RRenal insufficiency\n* Chronic hepatopathy\n* Epilepsy\n* Depression\n* Leucocytes \\<3000 or neutrophiles \\<1000 or thrombocytes \\<100000 or hemoglobin \\<12 gr/dL or ANA \\<1/80\n* Treatment with systemic steroids\n* Altered thyroid hormones\n* Previous resistance to PUVA and/or IFN\n* Hypersensitivity to IFN\n* Patients under treatment with teophiline and/or dicumarol\n* Previous total skin electron beam\n* Wash up period less than 3 month for IFN and /or PUVA\n* Wash up period less than 1 month for topical treatments'}, 'identificationModule': {'nctId': 'NCT00630903', 'acronym': 'MF99', 'briefTitle': 'PUVA Versus PUVA + IFN Alpha 2a in Mycosis Fungoides', 'organization': {'class': 'OTHER', 'fullName': 'Madrilenian Group of Cutaneous Lymphomas'}, 'officialTitle': 'Prospective, Randomized Multicentic to Compare PUVA+IFN Alpha 2a vs PUVA Alone in Mycosis Fungoides Stages Ia, Ib or IIa.', 'orgStudyIdInfo': {'id': 'MF99'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': '8-MOP + UVA x 24 weeks', 'interventionNames': ['Drug: PUVA (8-MOP + UVA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'IFN alone, 2 weeks, 8-MOP + UVA irradiation + IFN, 22 weeks', 'interventionNames': ['Drug: PUVA (8MOP + UVA) + IFN']}], 'interventions': [{'name': 'PUVA (8MOP + UVA) + IFN', 'type': 'DRUG', 'description': 'Weeks 3-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated) IFN: week1: 3, 6 and 9 MU (Mon, Wed, Fry). Weeks 2-24: 9MU 3 times a week)', 'armGroupLabels': ['B']}, {'name': 'PUVA (8-MOP + UVA)', 'type': 'DRUG', 'description': 'Weeks 1-24: 8.MOP: 0.6 MG/K, 3 times a week, 2 hours pre UVA irradiation (1-2 jul/cm2 according to phototype, increasing until 10 Jul/cm2, if tolerated)', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alcalá de Henares', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Príncipe de Asturias.', 'geoPoint': {'lat': 40.48205, 'lon': -3.35996}}, {'city': 'Getafe', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de Getafe', 'geoPoint': {'lat': 40.30571, 'lon': -3.73295}}, {'zip': '28009', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital de la Princess', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Gómez Ulla', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Francisco Vanaclocha Sebastián, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital 12 de Octubre'}, {'name': 'Jesús Fernández Herrera, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundación de Investigación Biomédica - Hospital Universitario de La Princesa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Madrilenian Group of Cutaneous Lymphomas', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr F Vanaclocha Sebastián', 'oldOrganization': 'Servicio de Dermatología. Hospital 12 de Octubre'}}}}