Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-25 @ 8:28 PM
Study NCT ID:
NCT00002669
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
2000-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D016898', 'term': 'Interferon-alpha'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003606', 'term': 'Dacarbazine'}], 'ancestors': [{'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'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014226', 'term': 'Triazenes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-29', 'studyFirstSubmitDate': '2000-06-02', 'studyFirstSubmitQcDate': '2003-04-10', 'lastUpdatePostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV melanoma', 'recurrent melanoma'], 'conditions': ['Melanoma (Skin)']}, 'referencesModule': {'references': [{'pmid': '19419855', 'type': 'BACKGROUND', 'citation': 'Agarwala SS, Keilholz U, Gilles E, Bedikian AY, Wu J, Kay R, Stein CA, Itri LM, Suciu S, Eggermont AM. LDH correlation with survival in advanced melanoma from two large, randomised trials (Oblimersen GM301 and EORTC 18951). Eur J Cancer. 2009 Jul;45(10):1807-14. doi: 10.1016/j.ejca.2009.04.016. Epub 2009 May 4.'}, {'type': 'BACKGROUND', 'citation': 'Keilholz U, Suciu S, Bedikian AY, et al.: LDH is a prognostic factor in stage IV melanoma patients (pts) but is a predictive factor only for bcl2 antisense treatment efficacy: re-analysis of GM301 and EORTC18951 randomized trials. [Abstract] J Clin Oncol 25 (Suppl 18): A-8552, 485s, 2007.'}, {'pmid': '10685668', 'type': 'BACKGROUND', 'citation': 'Keilholz U, Eggermont AM. The role of interleukin-2 in the management of stage IV melanoma: the EORTC melanoma cooperative group program. Cancer J Sci Am. 2000 Feb;6 Suppl 1:S99-103.'}, {'pmid': '17443000', 'type': 'RESULT', 'citation': 'Schmidt H, Suciu S, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, von der Maase H, Eggermont AM, Keilholz U; American Joint Committee on Cancer Stage IV Melanoma; EORTC 18951. Pretreatment levels of peripheral neutrophils and leukocytes as independent predictors of overall survival in patients with American Joint Committee on Cancer Stage IV Melanoma: results of the EORTC 18951 Biochemotherapy Trial. J Clin Oncol. 2007 Apr 20;25(12):1562-9. doi: 10.1200/JCO.2006.09.0274.'}, {'pmid': '17023156', 'type': 'RESULT', 'citation': 'Punt CJ, Suciu S, Gore MA, Koller J, Kruit WH, Thomas J, Patel P, Lienard D, Eggermont AM, Keilholz U. Chemoimmunotherapy with dacarbazine, cisplatin, interferon-alpha2b and interleukin-2 versus two cycles of dacarbazine followed by chemoimmunotherapy in patients with metastatic melanoma: a randomised phase II study of the European Organization for Research and Treatment of Cancer Melanoma Group. Eur J Cancer. 2006 Nov;42(17):2991-5. doi: 10.1016/j.ejca.2006.08.012. Epub 2006 Oct 4.'}, {'pmid': '16170182', 'type': 'RESULT', 'citation': 'Keilholz U, Punt CJ, Gore M, Kruit W, Patel P, Lienard D, Thomas J, Proebstle TM, Schmittel A, Schadendorf D, Velu T, Negrier S, Kleeberg U, Lehman F, Suciu S, Eggermont AM. Dacarbazine, cisplatin, and interferon-alfa-2b with or without interleukin-2 in metastatic melanoma: a randomized phase III trial (18951) of the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol. 2005 Sep 20;23(27):6747-55. doi: 10.1200/JCO.2005.03.202.'}, {'type': 'RESULT', 'citation': 'Keilholz U, Punt CJ, Gore M, et al.: Dacarbazine, cisplatin and interferon alpha with or without interleukin-2 in advanced melanoma: interim analysis of EORTC trial 18951. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A2043, 530a, 1999.'}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of the cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known which treatment regimen is more effective in treating melanoma.\n\nPURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of combination chemotherapy plus interferon alfa and interleukin-2 in treating patients who have metastatic melanoma.", 'detailedDescription': 'OBJECTIVES:\n\n* Assess the rate of disease stabilization in patients with metastatic melanoma when treated with interferon alfa, dacarbazine, cisplatin, and interleukin-2.\n* Assess toxicity, overall response rate, and response duration in these patients when treated with this regimen.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to center. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive dacarbazine IV over 1 hour and cisplatin IV over 3 hours on days 1-3. Patients also receive interferon alfa subcutaneously (SQ) on days 1-5 and interleukin-2 by continuous IV infusion on days 4-9. Treatment continues every 28 days for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive dacarbazine IV on day 1 and 22 every 28 days for 2 courses. Patients then receive treatment as in arm I for a maximum of 4 courses.\n\nPatients are followed every 2 months for 6 months, then every 3 months thereafter.\n\nPROJECTED ACCRUAL: A total of 42-90 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed melanoma that is metastatic and unresectable\n* Measurable, progressive disease (by physical exam and/or noninvasive imaging)\n\n * No prior irradiation of indicator lesions\n* No CNS metastases (confirmed by CT or MRI)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 70\n\nPerformance status:\n\n* Karnofsky 60-100%\n\nLife expectancy:\n\n* Greater than 3 months\n\nHematopoietic:\n\n* WBC at least 2,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* No serious hepatic disease\n\nRenal:\n\n* Creatinine no greater than 1.65 mg/dL\n* No serious renal disease\n\nCardiovascular:\n\n* No serious cardiac disease\n\nPulmonary:\n\n* No serious pulmonary disease\n\nOther:\n\n* No organ allograft\n* No autoimmune disease\n* No uncontrolled infection\n* No active peptic ulcer\n* No hyper or hypothyroidism\n* No requirement for corticosteroids\n* No second malignancy except basal cell skin carcinoma or carcinoma in situ of the cervix\n* Not pregnant or nursing\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy with interleukin-2\n* No prior interferon alfa in combination with cisplatin or dacarbazine\n\nChemotherapy:\n\n* No prior chemotherapy with cisplatin in combination with dacarbazine\n* More than 3 months since prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Prior radiotherapy allowed\n\nSurgery:\n\n* Not specified'}, 'identificationModule': {'nctId': 'NCT00002669', 'briefTitle': 'Combination Chemotherapy, Interferon Alfa, and Interleukin-2 in Treating Patients With Metastatic Melanoma', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'TREATMENT OF METASTATIC MELANOMA WITH DTIC, CDDP AND IFN ALPHA WITH OR WITHOUT IL-2: A RANDOMIZED PHASE III TRIAL', 'orgStudyIdInfo': {'id': 'EORTC-18951'}, 'secondaryIdInfos': [{'id': 'EORTC-18951'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'aldesleukin', 'type': 'BIOLOGICAL'}, {'name': 'recombinant interferon alfa', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'dacarbazine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenanstalten - Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hopital Universitaire Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1000', 'city': 'Brussels (Bruxelles)', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHR de Besancon - Hopital Saint-Jacques', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '69373', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Leon Berard', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '75651', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': 'D-10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitaetsklinikum Charite', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Universitaetsklinikum Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-13122', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Robert Roessle Klinik', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': 'D-22765', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Haematologisch-Onkologische Praxis Altona', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': 'D-55101', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Johannes Gutenberg University', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-68135', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'III Medizinische Klinik Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Europeo Di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Rotterdam Cancer Institute', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '4200', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': 'CH-1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitaetsspital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "St. James's Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Westcliff-on-Sea', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southend NHS Trust Hospital', 'geoPoint': {'lat': 51.54424, 'lon': 0.69179}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth Hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}], 'overallOfficials': [{'name': 'Ulrich Keilholz, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}