Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Status:
Completed
Trial end date:
2007-09-01
Target enrollment:
Participant gender:
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%).