Clinical trial NCT00911443: Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: sigma-tau i.f.r. S.p.A.
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).


Eligibility 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

Primary outcomes:
measure: Overall Tumor Response
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Progression Free Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: La Tronche
country: France
facility: CHU de Grenoble Hopital Albert Michallon Service de Dermatologie
city: Limoges
country: France
facility: CHU de Limoges Hopital Dupuytren Service de Dermatologie
city: Montpellier
country: France
facility: Hopital Saint-Eloi Service de Dermatologie
city: Rennes
country: France
facility: Centre Eugene Marquis Departement d'Oncologie Medicale
city: Toulouse
country: France
facility: Hopital Purpan Service de Dermatologie
city: Aachen
country: Germany
facility: Klinik fur Dermatologie und Allergologie der RWTH Aachen
city: Berlin
country: Germany
facility: Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte
city: Buxtehude
country: Germany
facility: Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie
city: Frankfurt
country: Germany
facility: Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat
city: Hannover
country: Germany
facility: Klinikum Hannover, Hautklinik Linden
city: Kiel
country: Germany
facility: Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel
city: Magdeburg
country: Germany
facility: Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg
city: Tubingen
country: Germany
facility: Dermatologische Klinik der Universitat Tubingen
city: Budapest
country: Hungary
facility: Orszagos Bor-es Nemikortani Intezet
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet Borgyogyaszat
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz, Borgyogyaszat
city: Miskolc
country: Hungary
facility: Miskolc Megyei Korhaz Borgyogyaszat
city: Pecs
country: Hungary
facility: Pecsi Egyetem Borgyogyaszati Klinika
city: Szeged
country: Hungary
facility: Szegedi Egyetem Borgyogyaszati Klinika
city: Sora
country: Italy
facility: Ospedale SS Trinità Oncologia
state: Frosinone
city: Taormina
country: Italy
facility: Ospedale San Vincenzo U.O. Oncologia Medica
state: Messina
city: Albano Laziale
country: Italy
facility: UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe
state: Roma
city: Noale
country: Italy
facility: Ospedale PF Calvi Dipartimento di Oncologia
state: Venezia
city: Agrigento
country: Italy
facility: ASL 1 Servizio di Oncologia
city: Caltanissetta
country: Italy
facility: Azienda Ospedaliera S. Elia, UO di Oncologia
city: Catania
country: Italy
facility: Azienda Ospedaliera Garibaldi, UO Oncologia Medica
city: Chieti
country: Italy
facility: Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica
city: Enna
country: Italy
facility: Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia
city: Firenze
country: Italy
facility: Università di Firenze Dipartimento di Scienze Dermatologiche
city: Forli
country: Italy
facility: Ospedale Pierantoni, Divisione Oncologia Medica
city: Genova
country: Italy
facility: Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia, Divisione di Chirurgia Generale
city: Milano
country: Italy
facility: Casa di Cura San Pio X, UO Oncologia Medica
city: Ragusa
country: Italy
facility: Ospedale Civile, UO di Oncologia
city: Reggio Calabria
country: Italy
facility: Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica
city: Roma
country: Italy
facility: Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia
city: Roma
country: Italy
facility: IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A
city: Roma
country: Italy
facility: Ospedale Sandro Pertini, Oncologia Medica
city: Roma
country: Italy
facility: Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia
city: Siena
country: Italy
facility: Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia
city: Siena
country: Italy
facility: U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"
city: Siracusa
country: Italy
facility: Ospedale Umberto I°, Divisione di Oncologia Medica
city: Viterbo
country: Italy
facility: Ospedale Bel Colle UO di Oncologia
city: Gdansk
country: Poland
facility: Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna
city: Krakow
country: Poland
facility: Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej
city: Poznan
country: Poland
facility: Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM
city: Szczecin
country: Poland
facility: Oddzial Chemioterapii
city: Warszawa
country: Poland
facility: Klinika Onkologii Centralnego Szpitala WAM
city: Wroclaw
country: Poland
facility: Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3
city: L'hospitalet de Llobregat
country: Spain
facility: Instituto Catalan Oncologico, Servicio de Oncologia
state: Barcelona
city: La Laguna
country: Spain
facility: Hosp. Univ. de Canarias Servicio de Oncologia Medica
state: Santa Cruz de Tenerife
city: Barcelona
country: Spain
facility: Hosp. Clinic i Provincial Servicio de Oncologia
city: Jaen
country: Spain
facility: Hosp. Universitario de Jaen Servicio de Oncologia
city: Madrid
country: Spain
facility: Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano
city: Malaga
country: Spain
facility: Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos
city: Sevilla
country: Spain
facility: Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico
city: Valencia
country: Spain
facility: Instituto Valenciano Oncologico
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia Unidad de Oncologia Medica
city: Aarau
country: Switzerland
facility: Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau
Study officials:
affiliation: IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
name: Virginia Ferraresi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sigma-Tau SpA
name: Roberto Camerini, MD
role: STUDY_DIRECTOR
References: