Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma

This study has been completed.
Sponsor:
Information provided by:
sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier:
NCT00911443
First received: February 26, 2009
Last updated: July 1, 2009
Last verified: July 2009
  Purpose

The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.

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%).


Condition Intervention Phase
Malignant Melanoma
Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg
Drug: Dacarbazine + Interferon alpha
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in Patients With Advanced -Stage Metastatic Malignant Melanoma

Resource links provided by NLM:


Further study details as provided by sigma-tau i.f.r. S.p.A.:

Primary Outcome Measures:
  • Overall Tumor Response [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 488
Study Start Date: July 2002
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
  • Roferon
Experimental: 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.
Biological: 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.
Other Names:
  • Zadaxin
  • Thymalfasin
  • ST1472
  • Deticene
Active Comparator: 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.
Drug: 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 Names:
  • Deticene
  • Roferon

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have read and signed the informed consent form
  • 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:

  • Clinical diagnosis of autoimmune disease
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911443

  Hide Study Locations
Locations
France
CHU de Grenoble Hopital Albert Michallon Service de Dermatologie
La Tronche, France, 38043
CHU de Limoges Hopital Dupuytren Service de Dermatologie
Limoges, France, 87042
Hopital Saint-Eloi Service de Dermatologie
Montpellier, France, 34295
Centre Eugene Marquis Departement d'Oncologie Medicale
Rennes, France, 35042
Hopital Purpan Service de Dermatologie
Toulouse, France, 31059
Germany
Klinik fur Dermatologie und Allergologie der RWTH Aachen
Aachen, Germany, 52074
Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte
Berlin, Germany, 10117
Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie
Buxtehude, Germany, 21614
Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat
Frankfurt, Germany, 60590
Klinikum Hannover, Hautklinik Linden
Hannover, Germany, D-30449
Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel
Kiel, Germany, 24105
Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg
Magdeburg, Germany, 39120
Dermatologische Klinik der Universitat Tubingen
Tubingen, Germany, 72076
Hungary
Orszagos Bor-es Nemikortani Intezet
Budapest, Hungary, H-1085
Orszagos Onkologiai Intezet Borgyogyaszat
Budapest, Hungary, H-1122
Petz Aladar Megyei Korhaz, Borgyogyaszat
Gyor, Hungary, H-9024
Miskolc Megyei Korhaz Borgyogyaszat
Miskolc, Hungary, H-3501
Pecsi Egyetem Borgyogyaszati Klinika
Pecs, Hungary, H-7600
Szegedi Egyetem Borgyogyaszati Klinika
Szeged, Hungary, H-6701
Italy
Ospedale SS Trinità Oncologia
Sora, Frosinone, Italy, 03039
Ospedale San Vincenzo U.O. Oncologia Medica
Taormina, Messina, Italy, 98039
UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe
Albano Laziale, Roma, Italy, 00041
Ospedale PF Calvi Dipartimento di Oncologia
Noale, Venezia, Italy, 30033
ASL 1 Servizio di Oncologia
Agrigento, Italy
Azienda Ospedaliera S. Elia, UO di Oncologia
Caltanissetta, Italy, 93100
Azienda Ospedaliera Garibaldi, UO Oncologia Medica
Catania, Italy, 95126
Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica
Chieti, Italy, 66100
Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia
Enna, Italy, 94100
Università di Firenze Dipartimento di Scienze Dermatologiche
Firenze, Italy, 50121
Ospedale Pierantoni, Divisione Oncologia Medica
Forli, Italy, 47100
Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1
Genova, Italy, 16132
Casa di Cura San Pio X, UO Oncologia Medica
Milano, Italy, 20159
Istituto Europeo di Oncologia, Divisione di Chirurgia Generale
Milano, Italy, 20141
Ospedale Civile, UO di Oncologia
Ragusa, Italy, 97100
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica
Reggio Calabria, Italy, 89100
Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva
Roma, Italy, 00161
Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia
Roma, Italy, 00133
Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia
Roma, Italy, 00167
IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A
Roma, Italy, 00144
Ospedale Sandro Pertini, Oncologia Medica
Roma, Italy, 00157
Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia
Siena, Italy, 53100
U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"
Siena, Italy, 53100
Ospedale Umberto I°, Divisione di Oncologia Medica
Siracusa, Italy, 96100
Ospedale Bel Colle UO di Oncologia
Viterbo, Italy, 01100
Poland
Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna
Gdansk, Poland, 80-211
Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii
Krakow, Poland, 31-115
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej
Lodz, Poland, 93-509
Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej
Lublin, Poland, 20-081
Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM
Poznan, Poland, 61-868
Oddzial Chemioterapii
Szczecin, Poland, 71-730
Klinika Onkologii Centralnego Szpitala WAM
Warszawa, Poland
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
Wroclaw, Poland, 53-439
Portugal
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C
Lisboa, Portugal, 1099-023
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3
Porto, Portugal, 4200
Spain
Instituto Catalan Oncologico, Servicio de Oncologia
L'hospitalet de Llobregat, Barcelona, Spain, 08907
Hosp. Univ. de Canarias Servicio de Oncologia Medica
La Laguna, Santa Cruz de Tenerife, Spain, 38320
Hosp. Clinic i Provincial Servicio de Oncologia
Barcelona, Spain, 08036
Hosp. Universitario de Jaen Servicio de Oncologia
Jaen, Spain, 23007
Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano
Madrid, Spain, 28040
Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos
Malaga, Spain, 29010
Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico
Sevilla, Spain, 41013
Instituto Valenciano Oncologico
Valencia, Spain, 46009
Hospital General Universitario de Valencia Unidad de Oncologia Medica
Valencia, Spain, 46014
Switzerland
Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Sponsors and Collaborators
sigma-tau i.f.r. S.p.A.
Investigators
Principal Investigator: Virginia Ferraresi, MD IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
Study Director: Roberto Camerini, MD Sigma-Tau SpA
  More Information

No publications provided

Responsible Party: ROBERTO CAMERINI / Head of Clinical Research II, sigma-tau i.f.r. S.p.A.
ClinicalTrials.gov Identifier: NCT00911443     History of Changes
Other Study ID Numbers: ST1472DM01012
Study First Received: February 26, 2009
Results First Received: February 26, 2009
Last Updated: July 1, 2009
Health Authority: Italy: Ethics Committee
Germany: Ethics Commission
France: Institutional Ethical Committee
Spain: Ethics Committee
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Switzerland: Swissmedic
Portugal: Ethics Committee for Clinical Research

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferons
Thymalfasin
Dacarbazine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 29, 2014