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

PHASE2CompletedINTERVENTIONAL
Enrollment

488

Participants

Timeline

Start Date

July 31, 2002

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Malignant Melanoma
Interventions
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.

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.

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.

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.

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.

Trial Locations (64)

4200

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

10117

Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte, Berlin

16132

Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1, Genova

20141

Istituto Europeo di Oncologia, Divisione di Chirurgia Generale, Milan

20159

Casa di Cura San Pio X, UO Oncologia Medica, Milan

21614

Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie, Buxtehude

23007

Hosp. Universitario de Jaen Servicio de Oncologia, Jaén

24105

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

28040

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

29010

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

30033

Ospedale PF Calvi Dipartimento di Oncologia, Noale

31059

Hopital Purpan Service de Dermatologie, Toulouse

34295

Hopital Saint-Eloi Service de Dermatologie, Montpellier

35042

Centre Eugene Marquis Departement d'Oncologie Medicale, Rennes

38043

CHU de Grenoble Hopital Albert Michallon Service de Dermatologie, La Tronche

38320

Hosp. Univ. de Canarias Servicio de Oncologia Medica, San Cristóbal de La Laguna

39120

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

41013

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

46009

Instituto Valenciano Oncologico, Valencia

46014

Hospital General Universitario de Valencia Unidad de Oncologia Medica, Valencia

47100

Ospedale Pierantoni, Divisione Oncologia Medica, Forlì

50121

Università di Firenze Dipartimento di Scienze Dermatologiche, Florence

52074

Klinik fur Dermatologie und Allergologie der RWTH Aachen, Aachen

53100

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

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

60590

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

66100

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

72076

Dermatologische Klinik der Universitat Tubingen, Tübingen

87042

CHU de Limoges Hopital Dupuytren Service de Dermatologie, Limoges

89100

Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica, Reggio Calabria

93100

Azienda Ospedaliera S. Elia, UO di Oncologia, Caltanissetta

94100

Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia, Enna

95126

Azienda Ospedaliera Garibaldi, UO Oncologia Medica, Catania

96100

Ospedale Umberto I°, Divisione di Oncologia Medica, Syracuse

97100

Ospedale Civile, UO di Oncologia, Ragusa

98039

Ospedale San Vincenzo U.O. Oncologia Medica, Taormina

D-30449

Klinikum Hannover, Hautklinik Linden, Hanover

H-1085

Orszagos Bor-es Nemikortani Intezet, Budapest

H-1122

Orszagos Onkologiai Intezet Borgyogyaszat, Budapest

H-9024

Petz Aladar Megyei Korhaz, Borgyogyaszat, Győr

H-3501

Miskolc Megyei Korhaz Borgyogyaszat, Miskolc

H-7600

Pecsi Egyetem Borgyogyaszati Klinika, Pécs

H-6701

Szegedi Egyetem Borgyogyaszati Klinika, Szeged

03039

Ospedale SS Trinità Oncologia, Sora

00041

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

Unknown

ASL 1 Servizio di Oncologia, Agrigento

Klinika Onkologii Centralnego Szpitala WAM, Warsaw

00133

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

00144

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

00157

Ospedale Sandro Pertini, Oncologia Medica, Roma

00161

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

00167

Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia, Roma

01100

Ospedale Bel Colle UO di Oncologia, Viterbo

80-211

Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna, Gdansk

31-115

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

93-509

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

20-081

Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej, Lublin

61-868

Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM, Poznan

71-730

Oddzial Chemioterapii, Szczecin

53-439

Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw

1099-023

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

08907

Instituto Catalan Oncologico, Servicio de Oncologia, L'Hospitalet de Llobregat

08036

Hosp. Clinic i Provincial Servicio de Oncologia, Barcelona

CH-5001

Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau, Aarau

All Listed Sponsors
lead

sigma-tau i.f.r. S.p.A.

INDUSTRY

NCT00911443 - Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma | Biotech Hunter | Biotech Hunter