Completed
PHASE2
INTERVENTIONAL
NCT00911443
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
View on ClinicalTrials.gov
Updated Dec 15, 2025
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%).
Interventions
Name:
Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
Type:
BIOLOGICAL
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.
Name:
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Type:
BIOLOGICAL
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.
Name:
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Type:
BIOLOGICAL
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.
Name:
Dacarbazine + Thymosin-alpha-1 3.2 mg
Type:
BIOLOGICAL
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.
Name:
Dacarbazine + Interferon alpha
Type:
DRUG
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 Outcomes
Measure:
Overall Tumor Response
TimeFrame:
1 year
Description:
Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
Trial Information
NCT ID
NCT00911443
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
sigma-tau i.f.r. S.p.A.
Last Updated
December 15, 2025