NCT00911443

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 488 (actual)
• Sponsor: sigma-tau i.f.r. S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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%).

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg	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 + Interferon alpha + Thymosin-alpha-1 3.2 mg	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 + Interferon alpha + Thymosin-alpha-1 6.4 mg	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 + Thymosin-alpha-1 3.2 mg	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 + Interferon alpha	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

• Start date: 2002-07-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2009-06-02
• Last updated: 2009-07-09
• Results posted: 2009-06-02

Locations

64 sites across 8 countries: France, Germany, Hungary, Italy, Poland, Portugal, Spain, Switzerland