Status
Completed
Phase
Phase 2
Enrollment
488
Locations
64
Results
Posted
Publications
0
Study 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%).
Interventions
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.
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.
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.
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.
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.
Timeline
First posted
Jun 2, 2009
Study start
Jul 2002
Primary completion
Sep 2007
Study completion
Sep 2007
Results posted
Jun 2, 2009
Registry updated
Jul 9, 2009
Outcomes
Overall Tumor Response
Time frame · 1 year
Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
Overall Survival
Time frame · 2 years
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
Time frame · 2 years
Progression Free Survival is defined as the time from the randomization to progression or death
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 locations
France · Germany · Hungary · Italy · Poland · Portugal · Spain · Switzerland. Showing up to 24 locations stored in the fast local snapshot.
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, France
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
Hanover, 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
Tübingen, Germany
Orszagos Bor-es Nemikortani Intezet
Budapest, Hungary
Orszagos Onkologiai Intezet Borgyogyaszat
Budapest, Hungary
Petz Aladar Megyei Korhaz, Borgyogyaszat
Győr, Hungary
Miskolc Megyei Korhaz Borgyogyaszat
Miskolc, Hungary
Pecsi Egyetem Borgyogyaszati Klinika
Pécs, Hungary
Szegedi Egyetem Borgyogyaszati Klinika
Szeged, Hungary
Ospedale SS Trinità Oncologia
Sora, FROSINONE, Italy
Ospedale San Vincenzo U.O. Oncologia Medica
Taormina, MESSINA, Italy
UO Complessa Aziendale Nettuno/Albano/Frascati Day-Hospital di Oncologia Ospedale S. Giuseppe
Albano Laziale, ROMA, Italy
Ospedale PF Calvi Dipartimento di Oncologia
Noale, VENEZIA, Italy
ASL 1 Servizio di Oncologia
Agrigento, Italy
Publications
No PMID-linked publications were present in this registry snapshot.
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