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More info
You can access this
clinical trial
if you have
Malignant Melanoma
and you are
between 18 and 75
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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%).

Provided treatments

  • Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg
  • Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
  • Biological: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
  • Biological: Dacarbazine + Thymosin-alpha-1 3.2 mg
  • Drug: Dacarbazine + Interferon alpha
Tris trial is registered with FDA with number: NCT00911443. The sponsor of the trial is sigma-tau i.f.r. S.p.A. and it is looking for 488 volunteers for the current phase.
Official trial 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