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

Malignant Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911443
• Other study ID #: ST1472DM01012
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: July 1, 2009
• Start date: July 2002
• Est. completion date: September 2007

Study information

• Verified date: July 2009
• Source: sigma-tau i.f.r. S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeGermany: Ethics CommissionFrance: Institutional Ethical CommitteeSpain: Ethics CommitteePoland: Ministry of HealthHungary: National Institute of PharmacySwitzerland: SwissmedicPortugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

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.
• 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.
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
sigma-tau i.f.r. S.p.A.

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Italy,  Poland,  Portugal,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Tumor Response		1 year	No
Secondary	Overall Survival		2 years	No
Secondary	Progression Free Survival		2 years	No