Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
NCT ID: NCT00911443
Last Updated: 2009-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
488 participants
INTERVENTIONAL
2002-07-31
2007-09-30
Brief Summary
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Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.
Ninety-five patients are allocated to each arm to test the hypothesis that P0 \<= 0.05 vs the alternative hypothesis that P1 \>= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Dacarbazine 800 mg/m2 IV on day 1;Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Interventions
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Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Dacarbazine 800 mg/m2 IV on day 1;Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Dacarbazine + Interferon alpha
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years \<=Age\<= 75 years
* Adequate contraception practice (fertile female patient)
* Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases and \>= 1 measurable lesion
* Adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/deciliter (dl)
* Absolute Neutrophil Count (ANC) \>= 1.5 x 10000000000/L ; platelets \>= 100 x 10000000000/Liter (L)
* Good performance status: PS \<= 1 (ZUBROD-ECOG-WHO scale)
* At least 12 week life expectancy
Exclusion Criteria
* Transplant recipient
* Pregnancy documented by a urine pregnancy test or lactation
* Previous treatment with thymosin alpha 1
* Previous treatment with chemotherapy
* Presence of Central Nervous System (CNS) metastases
* Concomitant or prior history of malignancy other than melanoma
* Participation in another investigational trial within 30 days of study entry
* Active infectious process that is not of self-limiting nature
18 Years
75 Years
ALL
No
Sponsors
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sigma-tau i.f.r. S.p.A.
INDUSTRY
Responsible Party
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sigma-tau i.f.r. S.p.A.
Principal Investigators
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Virginia Ferraresi, MD
Role: PRINCIPAL_INVESTIGATOR
IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
Roberto Camerini, MD
Role: STUDY_DIRECTOR
Sigma-Tau SpA
Locations
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CHU de Grenoble Hopital Albert Michallon Service de Dermatologie
La Tronche, , France
CHU de Limoges Hopital Dupuytren Service de Dermatologie
Limoges, , France
Hopital Saint-Eloi Service de Dermatologie
Montpellier, , France
Centre Eugene Marquis Departement d'Oncologie Medicale
Rennes, , France
Hopital Purpan Service de Dermatologie
Toulouse, , France
Klinik fur Dermatologie und Allergologie der RWTH Aachen
Aachen, , Germany
Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte
Berlin, , Germany
Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie
Buxtehude, , Germany
Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat
Frankfurt, , Germany
Klinikum Hannover, Hautklinik Linden
Hanover, , Germany
Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel
Kiel, , Germany
Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg
Magdeburg, , Germany
Dermatologische Klinik der Universitat Tubingen
Tübingen, , Germany
Orszagos Bor-es Nemikortani Intezet
Budapest, , Hungary
Orszagos Onkologiai Intezet Borgyogyaszat
Budapest, , Hungary
Petz Aladar Megyei Korhaz, Borgyogyaszat
Győr, , Hungary
Miskolc Megyei Korhaz Borgyogyaszat
Miskolc, , Hungary
Pecsi Egyetem Borgyogyaszati Klinika
Pécs, , Hungary
Szegedi Egyetem Borgyogyaszati Klinika
Szeged, , Hungary
Ospedale SS Trinità Oncologia
Sora, FROSINONE, Italy
Ospedale San Vincenzo U.O. Oncologia Medica
Taormina, MESSINA, Italy
UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe
Albano Laziale, ROMA, Italy
Ospedale PF Calvi Dipartimento di Oncologia
Noale, VENEZIA, Italy
ASL 1 Servizio di Oncologia
Agrigento, , Italy
Azienda Ospedaliera S. Elia, UO di Oncologia
Caltanissetta, , Italy
Azienda Ospedaliera Garibaldi, UO Oncologia Medica
Catania, , Italy
Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica
Chieti, , Italy
Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia
Enna, , Italy
Università di Firenze Dipartimento di Scienze Dermatologiche
Florence, , Italy
Ospedale Pierantoni, Divisione Oncologia Medica
Forlì, , Italy
Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1
Genova, , Italy
Istituto Europeo di Oncologia, Divisione di Chirurgia Generale
Milan, , Italy
Casa di Cura San Pio X, UO Oncologia Medica
Milan, , Italy
Ospedale Civile, UO di Oncologia
Ragusa, , Italy
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica
Reggio Calabria, , Italy
Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia
Roma, , Italy
IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A
Roma, , Italy
Ospedale Sandro Pertini, Oncologia Medica
Roma, , Italy
Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva
Roma, , Italy
Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia
Roma, , Italy
Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia
Siena, , Italy
U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"
Siena, , Italy
Ospedale Umberto I°, Divisione di Oncologia Medica
Syracuse, , Italy
Ospedale Bel Colle UO di Oncologia
Viterbo, , Italy
Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna
Gdansk, , Poland
Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej
Lublin, , Poland
Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM
Poznan, , Poland
Oddzial Chemioterapii
Szczecin, , Poland
Klinika Onkologii Centralnego Szpitala WAM
Warsaw, , Poland
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, , Poland
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C
Lisbon, , Portugal
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3
Porto, , Portugal
Instituto Catalan Oncologico, Servicio de Oncologia
L'Hospitalet de Llobregat, BARCELONA, Spain
Hosp. Univ. de Canarias Servicio de Oncologia Medica
San Cristóbal de La Laguna, SANTA CRUZ DE TENERIFE, Spain
Hosp. Clinic i Provincial Servicio de Oncologia
Barcelona, , Spain
Hosp. Universitario de Jaen Servicio de Oncologia
Jaén, , Spain
Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano
Madrid, , Spain
Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos
Málaga, , Spain
Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico
Seville, , Spain
Instituto Valenciano Oncologico
Valencia, , Spain
Hospital General Universitario de Valencia Unidad de Oncologia Medica
Valencia, , Spain
Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau
Aarau, , Switzerland
Countries
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Other Identifiers
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ST1472DM01012
Identifier Type: -
Identifier Source: org_study_id
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