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

Primary Purpose

Malignant Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine + Interferon alpha
Sponsored by
sigma-tau i.f.r. S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

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

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

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

Dacarbazine + Thymosin-alpha-1 3.2 mg

Dacarbazine + Interferon alpha

Arm Description

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 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 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 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 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Progression Free Survival
Progression Free Survival is defined as the time from the randomization to progression or death

Full Information

First Posted
February 26, 2009
Last Updated
July 1, 2009
Sponsor
sigma-tau i.f.r. S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00911443
Brief Title
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

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
sigma-tau i.f.r. S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Dacarbazine + Thymosin-alpha-1 3.2 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Dacarbazine + Interferon alpha
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Other Intervention Name(s)
Zadaxin, Thymalfasin, ST1472, Deticene, Roferon
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Other Intervention Name(s)
Zadaxin, Thymalfasin, ST1472, Deticene, Roferon
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Other Intervention Name(s)
Zadaxin, Thymalfasin, ST1472, Deticene, Roferon
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Dacarbazine + Thymosin-alpha-1 3.2 mg
Other Intervention Name(s)
Zadaxin, Thymalfasin, ST1472, Deticene
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dacarbazine + Interferon alpha
Other Intervention Name(s)
Deticene, Roferon
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Tumor Response
Description
Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Overall Survival
Description
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.
Time Frame
2 years
Title
Progression Free Survival
Description
Progression Free Survival is defined as the time from the randomization to progression or death
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginia Ferraresi, MD
Organizational Affiliation
IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roberto Camerini, MD
Organizational Affiliation
Sigma-Tau SpA
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Grenoble Hopital Albert Michallon Service de Dermatologie
City
La Tronche
ZIP/Postal Code
38043
Country
France
Facility Name
CHU de Limoges Hopital Dupuytren Service de Dermatologie
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Saint-Eloi Service de Dermatologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Eugene Marquis Departement d'Oncologie Medicale
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Hopital Purpan Service de Dermatologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Klinik fur Dermatologie und Allergologie der RWTH Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Klinik fur Dermatologie, Venerologie und Allergologie des Campus Charitè Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Elbeklinikec Buxtehude Dermatologische Zentrum Abteilung fur Dermato-Onkologie
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Zentrum fur Dermatologie und Veneralogie Klinik der Johann-Wolfgang-Goethe-Universitat
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Klinikum Hannover, Hautklinik Linden
City
Hannover
ZIP/Postal Code
D-30449
Country
Germany
Facility Name
Universitatsklinikum Schlewig-Holstein Klinik fur Dermatologie, Veneralogie und Allergologie Universitats-Hautklinik Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitatsklinik fur Dermatologie und Venerologie Otto-von-Guericke-Universitat Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Dermatologische Klinik der Universitat Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Orszagos Bor-es Nemikortani Intezet
City
Budapest
ZIP/Postal Code
H-1085
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet Borgyogyaszat
City
Budapest
ZIP/Postal Code
H-1122
Country
Hungary
Facility Name
Petz Aladar Megyei Korhaz, Borgyogyaszat
City
Gyor
ZIP/Postal Code
H-9024
Country
Hungary
Facility Name
Miskolc Megyei Korhaz Borgyogyaszat
City
Miskolc
ZIP/Postal Code
H-3501
Country
Hungary
Facility Name
Pecsi Egyetem Borgyogyaszati Klinika
City
Pecs
ZIP/Postal Code
H-7600
Country
Hungary
Facility Name
Szegedi Egyetem Borgyogyaszati Klinika
City
Szeged
ZIP/Postal Code
H-6701
Country
Hungary
Facility Name
Ospedale SS Trinità Oncologia
City
Sora
State/Province
Frosinone
ZIP/Postal Code
03039
Country
Italy
Facility Name
Ospedale San Vincenzo U.O. Oncologia Medica
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Facility Name
UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe
City
Albano Laziale
State/Province
Roma
ZIP/Postal Code
00041
Country
Italy
Facility Name
Ospedale PF Calvi Dipartimento di Oncologia
City
Noale
State/Province
Venezia
ZIP/Postal Code
30033
Country
Italy
Facility Name
ASL 1 Servizio di Oncologia
City
Agrigento
Country
Italy
Facility Name
Azienda Ospedaliera S. Elia, UO di Oncologia
City
Caltanissetta
ZIP/Postal Code
93100
Country
Italy
Facility Name
Azienda Ospedaliera Garibaldi, UO Oncologia Medica
City
Catania
ZIP/Postal Code
95126
Country
Italy
Facility Name
Università "G. D'Annunzio" Facoltà di Medicina e Chirurgia, Clinica Dermatologica
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Azienda Ospedaliera Umberto I° UO Servizio di Oncologia e Chemioterapia
City
Enna
ZIP/Postal Code
94100
Country
Italy
Facility Name
Università di Firenze Dipartimento di Scienze Dermatologiche
City
Firenze
ZIP/Postal Code
50121
Country
Italy
Facility Name
Ospedale Pierantoni, Divisione Oncologia Medica
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
Istituto NazionaleRicerca sul Cancro, Dipartimento di Oncologia Medica 1
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Istituto Europeo di Oncologia, Divisione di Chirurgia Generale
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Casa di Cura San Pio X, UO Oncologia Medica
City
Milano
ZIP/Postal Code
20159
Country
Italy
Facility Name
Ospedale Civile, UO di Oncologia
City
Ragusa
ZIP/Postal Code
97100
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi-Melacrino-Morelli, Oncologia Medica
City
Reggio Calabria
ZIP/Postal Code
89100
Country
Italy
Facility Name
Università di Roma "Tor Vergata" Oncologia Complementare, Dipartimento di Chirurgia
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
IFO Polo Oncologico Ist. Regina Elena, Divisione di Oncologia Medica A
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale Sandro Pertini, Oncologia Medica
City
Roma
ZIP/Postal Code
00157
Country
Italy
Facility Name
Università "La Sapienza" Dipartimento di Malattie Cutanee-Veneree e Chirurgia Plastica Ricostruttiva
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Istituto Dermopatico dell'Immacolata, Dipartimento di Immunodermatologia
City
Roma
ZIP/Postal Code
00167
Country
Italy
Facility Name
Policlinico "Le Scotte" Dipartimento di Medicina Clinica, Scienze Immunologiche Applicate, Divisione di Dermatologia
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
U.O. Complessa, Immunoterapia Oncologica, Policlinico "Le Scotte"
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ospedale Umberto I°, Divisione di Oncologia Medica
City
Siracusa
ZIP/Postal Code
96100
Country
Italy
Facility Name
Ospedale Bel Colle UO di Oncologia
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Katedra i Klinika Onkologii i Radioterapii Akademia Medyczna
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Instytut Onkologii im. Marii Sklodowskiej-Curie, Oddzial w Krakowie, Klinika Chemioterapii
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Klinika Chemioterapii Oncologicznej
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 1, Klinika Chirurgii Onkologicznej
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii, Zaklad Immunologii Nowotworow Katedry Onkologii AM
City
Poznan
ZIP/Postal Code
61-868
Country
Poland
Facility Name
Oddzial Chemioterapii
City
Szczecin
ZIP/Postal Code
71-730
Country
Poland
Facility Name
Klinika Onkologii Centralnego Szpitala WAM
City
Warszawa
Country
Poland
Facility Name
Dolnoslakie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku
City
Wroclaw
ZIP/Postal Code
53-439
Country
Poland
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia de Lisboa S.A., Servicio de Medicina Oncologica 1, Pavilhao C
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil, Centro Regional de Oncologia do Porto S.A., Servicio de Medicina Oncologica, Piso 3
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Instituto Catalan Oncologico, Servicio de Oncologia
City
L'hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hosp. Univ. de Canarias Servicio de Oncologia Medica
City
La Laguna
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hosp. Clinic i Provincial Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hosp. Universitario de Jaen Servicio de Oncologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Hosp. Clinico San Carlos Servicio de Oncologia, Pabellon B, Ala Sur-Sotano
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hosp. Virgen de la Victoria de Malaga Servicio de Oncologia 1a planta Campus Universitario de Teatinos
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hosp. Virgen del Rocio Servicio de Oncologia, Planta Baja - Centro de Diagnostico
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano Oncologico
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Hospital General Universitario de Valencia Unidad de Oncologia Medica
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Zentrum fur Onkologie Hematologie und Transfusionsmedizin am Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland

12. IPD Sharing Statement

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

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