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

NCT00911443 | Completed Phase 2 Results

• 1 other identifier: ST1472DM01012
• Study Type: interventional
• Target: 488
• Locations: 8 countries
• Sites: 64

Brief Summary

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%).

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response

  Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response

  1 year

Secondary Outcomes (2)

• Overall Survival

  2 years

• Progression Free Survival

  2 years

Study Arms (5)

Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg

EXPERIMENTAL

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 + Interferon alpha + Thymosin-alpha-1 3.2 mg

EXPERIMENTAL

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 + Interferon alpha + Thymosin-alpha-1 6.4 mg

EXPERIMENTAL

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 + Thymosin-alpha-1 3.2 mg

EXPERIMENTAL

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 + Interferon alpha

ACTIVE COMPARATOR

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

Interventions

Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg BIOLOGICAL

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.

Also known as: Zadaxin, Thymalfasin, ST1472, Deticene, Roferon

Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg

Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg BIOLOGICAL

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.

Also known as: Zadaxin, Thymalfasin, ST1472, Deticene, Roferon

Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg

Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg BIOLOGICAL

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.

Also known as: Zadaxin, Thymalfasin, ST1472, Deticene, Roferon

Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg

Dacarbazine + Thymosin-alpha-1 3.2 mg BIOLOGICAL

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.

Also known as: Zadaxin, Thymalfasin, ST1472, Deticene

Dacarbazine + Thymosin-alpha-1 3.2 mg

Dacarbazine + Interferon alpha DRUG

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.

Also known as: Deticene, Roferon

Dacarbazine + Interferon alpha

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have read and signed the informed consent form
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.: lead

Study Sites (64)

CHU de Grenoble Hopital Albert Michallon Service de Dermatologie

La Tronche, 38043, France

Location

CHU de Limoges Hopital Dupuytren Service de Dermatologie

Limoges, 87042, France

Location

Hopital Saint-Eloi Service de Dermatologie

Montpellier, 34295, France

Location

Centre Eugene Marquis Departement d'Oncologie Medicale

Rennes, 35042, France

Location

Hopital Purpan Service de Dermatologie

Toulouse, 31059, France

Location

Klinik fur Dermatologie und Allergologie der RWTH Aachen

Aachen, 52074, Germany

Location

Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte

Berlin, 10117, Germany

Location

Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie

Buxtehude, 21614, Germany

Location

Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat

Frankfurt, 60590, Germany

Location

Klinikum Hannover, Hautklinik Linden

Hanover, D-30449, Germany

Location

Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel

Kiel, 24105, Germany

Location

Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg

Magdeburg, 39120, Germany

Location

Dermatologische Klinik der Universitat Tubingen

Tübingen, 72076, Germany

Location

Orszagos Bor-es Nemikortani Intezet

Budapest, H-1085, Hungary

Location

Orszagos Onkologiai Intezet Borgyogyaszat

Budapest, H-1122, Hungary

Location

Petz Aladar Megyei Korhaz, Borgyogyaszat

Győr, H-9024, Hungary

Location

Miskolc Megyei Korhaz Borgyogyaszat

Miskolc, H-3501, Hungary

Location

Pecsi Egyetem Borgyogyaszati Klinika

Pécs, H-7600, Hungary

Location

Szegedi Egyetem Borgyogyaszati Klinika

Szeged, H-6701, Hungary

Location

Ospedale SS Trinità Oncologia

Sora, FROSINONE, 03039, Italy

Location

Ospedale San Vincenzo U.O. Oncologia Medica

Taormina, MESSINA, 98039, Italy

Location

UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe

Albano Laziale, ROMA, 00041, Italy

Location

Ospedale PF Calvi Dipartimento di Oncologia

Noale, VENEZIA, 30033, Italy

Location

ASL 1 Servizio di Oncologia

Agrigento, Italy

Location

Azienda Ospedaliera S. Elia, UO di Oncologia

Caltanissetta, 93100, Italy

Location

Azienda Ospedaliera Garibaldi, UO Oncologia Medica

Catania, 95126, Italy

Location

Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica

Chieti, 66100, Italy

Location

Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia

Enna, 94100, Italy

Location

Università di Firenze Dipartimento di Scienze Dermatologiche

Florence, 50121, Italy

Location

Ospedale Pierantoni, Divisione Oncologia Medica

Forlì, 47100, Italy

Location

Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1

Genova, 16132, Italy

Location

Istituto Europeo di Oncologia, Divisione di Chirurgia Generale

Milan, 20141, Italy

Location

Casa di Cura San Pio X, UO Oncologia Medica

Milan, 20159, Italy

Location

Ospedale Civile, UO di Oncologia

Ragusa, 97100, Italy

Location

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica

Reggio Calabria, 89100, Italy

Location

Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia

Roma, 00133, Italy

Location

IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A

Roma, 00144, Italy

Location

Ospedale Sandro Pertini, Oncologia Medica

Roma, 00157, Italy

Location

Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva

Roma, 00161, Italy

Location

Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia

Roma, 00167, Italy

Location

Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia

Siena, 53100, Italy

Location

U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"

Siena, 53100, Italy

Location

Ospedale Umberto I°, Divisione di Oncologia Medica

Syracuse, 96100, Italy

Location

Ospedale Bel Colle UO di Oncologia

Viterbo, 01100, Italy

Location

Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna

Gdansk, 80-211, Poland

Location

Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii

Krakow, 31-115, Poland

Location

Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej

Lodz, 93-509, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej

Lublin, 20-081, Poland

Location

Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM

Poznan, 61-868, Poland

Location

Oddzial Chemioterapii

Szczecin, 71-730, Poland

Location

Klinika Onkologii Centralnego Szpitala WAM

Warsaw, Poland

Location

Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku

Wroclaw, 53-439, Poland

Location

Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C

Lisbon, 1099-023, Portugal

Location

Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3

Porto, 4200, Portugal

Location

Instituto Catalan Oncologico, Servicio de Oncologia

L'Hospitalet de Llobregat, BARCELONA, 08907, Spain

Location

Hosp. Univ. de Canarias Servicio de Oncologia Medica

San Cristóbal de La Laguna, SANTA CRUZ DE TENERIFE, 38320, Spain

Location

Hosp. Clinic i Provincial Servicio de Oncologia

Barcelona, 08036, Spain

Location

Hosp. Universitario de Jaen Servicio de Oncologia

Jaén, 23007, Spain

Location

Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano

Madrid, 28040, Spain

Location

Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos

Málaga, 29010, Spain

Location

Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico

Seville, 41013, Spain

Location

Instituto Valenciano Oncologico

Valencia, 46009, Spain

Location

Hospital General Universitario de Valencia Unidad de Oncologia Medica

Valencia, 46014, Spain

Location

Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

MeSH Terms

Conditions

Melanoma

Interventions

Dacarbazine; Interferon-alpha; Thymalfasin; Interferon alpha-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones

Results Point of Contact

• Title: Roberto Camerini
• Organization: R&D Department - Sigma-Tau SpA

roberto.camerini@sigma-tau.it

+390691393562

Study Officials

• Virginia Ferraresi, MD

  IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA

  PRINCIPAL INVESTIGATOR

• Roberto Camerini, MD

  Sigma-Tau SpA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: June 2, 2009
• Study Start: July 1, 2002
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: July 9, 2009
• Results First Posted: June 2, 2009

Record last verified: 2009-07

Locations

DE (8); PT (2); PL (8); CH (1); HU (6); ES (9); FR (5); IT (25)