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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored. | 2 years |
| Progression Free Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virginia Ferraresi, MD | IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA | Principal Investigator |
| Roberto Camerini, MD | Sigma-Tau SpA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Grenoble Hopital Albert Michallon Service de Dermatologie | La Tronche | 38043 | France | |||
| CHU de Limoges Hopital Dupuytren Service de Dermatologie |
Only patients who did not meet the entry selection criteria were excluded from study entry.
Recruitment started on August 2002 and has been completed on January 2006. All patients were recruited at medical clinic facilities (Oncology/Dermatology departments)
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| ID | Title | Description |
|---|---|---|
| FG000 | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | Dacarbazin 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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. |
|
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
Progression Free Survival is defined as the time from the randomization to progression or death
| 2 years |
| Limoges |
| 87042 |
| France |
| Hopital Saint-Eloi Service de Dermatologie | Montpellier | 34295 | France |
| Centre Eugene Marquis Departement d'Oncologie Medicale | Rennes | 35042 | France |
| Hopital Purpan Service de Dermatologie | Toulouse | 31059 | France |
| Klinik fur Dermatologie und Allergologie der RWTH Aachen | Aachen | 52074 | Germany |
| Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte | Berlin | 10117 | Germany |
| Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie | Buxtehude | 21614 | Germany |
| Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat | Frankfurt | 60590 | Germany |
| Klinikum Hannover, Hautklinik Linden | Hanover | D-30449 | Germany |
| Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel | Kiel | 24105 | Germany |
| Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg | Magdeburg | 39120 | Germany |
| Dermatologische Klinik der Universitat Tubingen | Tübingen | 72076 | Germany |
| Orszagos Bor-es Nemikortani Intezet | Budapest | H-1085 | Hungary |
| Orszagos Onkologiai Intezet Borgyogyaszat | Budapest | H-1122 | Hungary |
| Petz Aladar Megyei Korhaz, Borgyogyaszat | Győr | H-9024 | Hungary |
| Miskolc Megyei Korhaz Borgyogyaszat | Miskolc | H-3501 | Hungary |
| Pecsi Egyetem Borgyogyaszati Klinika | Pécs | H-7600 | Hungary |
| Szegedi Egyetem Borgyogyaszati Klinika | Szeged | H-6701 | Hungary |
| Ospedale SS Trinità Oncologia | Sora | FROSINONE | 03039 | Italy |
| Ospedale San Vincenzo U.O. Oncologia Medica | Taormina | MESSINA | 98039 | Italy |
| UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe | Albano Laziale | ROMA | 00041 | Italy |
| Ospedale PF Calvi Dipartimento di Oncologia | Noale | VENEZIA | 30033 | Italy |
| ASL 1 Servizio di Oncologia | Agrigento | Italy |
| Azienda Ospedaliera S. Elia, UO di Oncologia | Caltanissetta | 93100 | Italy |
| Azienda Ospedaliera Garibaldi, UO Oncologia Medica | Catania | 95126 | Italy |
| Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica | Chieti | 66100 | Italy |
| Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia | Enna | 94100 | Italy |
| Università di Firenze Dipartimento di Scienze Dermatologiche | Florence | 50121 | Italy |
| Ospedale Pierantoni, Divisione Oncologia Medica | Forlì | 47100 | Italy |
| Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1 | Genova | 16132 | Italy |
| Istituto Europeo di Oncologia, Divisione di Chirurgia Generale | Milan | 20141 | Italy |
| Casa di Cura San Pio X, UO Oncologia Medica | Milan | 20159 | Italy |
| Ospedale Civile, UO di Oncologia | Ragusa | 97100 | Italy |
| Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica | Reggio Calabria | 89100 | Italy |
| Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia | Roma | 00133 | Italy |
| IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A | Roma | 00144 | Italy |
| Ospedale Sandro Pertini, Oncologia Medica | Roma | 00157 | Italy |
| Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva | Roma | 00161 | Italy |
| Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia | Roma | 00167 | Italy |
| Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia | Siena | 53100 | Italy |
| U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte" | Siena | 53100 | Italy |
| Ospedale Umberto I°, Divisione di Oncologia Medica | Syracuse | 96100 | Italy |
| Ospedale Bel Colle UO di Oncologia | Viterbo | 01100 | Italy |
| Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna | Gdansk | 80-211 | Poland |
| Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii | Krakow | 31-115 | Poland |
| Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej | Lodz | 93-509 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej | Lublin | 20-081 | Poland |
| Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM | Poznan | 61-868 | Poland |
| Oddzial Chemioterapii | Szczecin | 71-730 | Poland |
| Klinika Onkologii Centralnego Szpitala WAM | Warsaw | Poland |
| Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | Wroclaw | 53-439 | Poland |
| 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 |
| Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3 | Porto | 4200 | Portugal |
| Instituto Catalan Oncologico, Servicio de Oncologia | L'Hospitalet de Llobregat | BARCELONA | 08907 | Spain |
| Hosp. Univ. de Canarias Servicio de Oncologia Medica | San Cristóbal de La Laguna | SANTA CRUZ DE TENERIFE | 38320 | Spain |
| Hosp. Clinic i Provincial Servicio de Oncologia | Barcelona | 08036 | Spain |
| Hosp. Universitario de Jaen Servicio de Oncologia | Jaén | 23007 | Spain |
| Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano | Madrid | 28040 | Spain |
| Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos | Málaga | 29010 | Spain |
| Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico | Seville | 41013 | Spain |
| Instituto Valenciano Oncologico | Valencia | 46009 | Spain |
| Hospital General Universitario de Valencia Unidad de Oncologia Medica | Valencia | 46014 | Spain |
| Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau | Aarau | CH-5001 | Switzerland |
| Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg |
Dacarbazin 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. |
| FG002 | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | Dacarbazin 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 cycle up to 6 cycles or until progression or unacceptable toxicity develops. |
| FG003 | Dacarbazin + Thymosin-alpha-1 3.2 mg | Dacarbazin 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. |
| FG004 | Dacarbazin + Interferon Alpha | Dacarbazin 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg | Dacarbazin 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. |
| BG001 | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg | Dacarbazin 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. |
| BG002 | Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg | Dacarbazin 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 cycle up to 6 cycles or until progression or unacceptable toxicity develops. |
| BG003 | Dacarbazin + Thymosin-alpha-1 3.2 mg | Dacarbazin 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. |
| BG004 | Dacarbazin + Interferon Alpha | Dacarbazin 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Overall Survival | The survival time for each patient is defined as the time between randomization and death. Patients lost to follow-up or still alive at the date of last evaluation have been censored. | Posted | Median | 95% Confidence Interval | months | 2 years |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival | Progression Free Survival is defined as the time from the randomization to progression or death | Posted | Median | 95% Confidence Interval | months | 2 years |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Tumor Response | Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response | Posted | Number | participants | 1 year |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Camerini | R&D Department - Sigma-Tau SpA | +390691393562 | roberto.camerini@sigma-tau.it |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D016898 | Interferon-alpha |
| D000077596 | Thymalfasin |
| D000077190 | Interferon alpha-2 |
| ID | Term |
|---|---|
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D013947 | Thymosin |
| D013951 | Thymus Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D036361 | Peptide Hormones |
Not provided
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Portugal |
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| Hungary |
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| Spain |
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| Poland |
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| Germany |
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| Switzerland |
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| Italy |
|
Dacarbazin 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. |
| OG004 | Dacarbazin + Interferon Alpha | Dacarbazin 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. |
|
|
| Dacarbazin + Thymosin-alpha-1 3.2 mg |
Dacarbazin 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. |
| OG004 | Dacarbazin + Interferon Alpha | Dacarbazin 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. |
|
|