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

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

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.

Sponsors & Collaborators

• sigma-tau i.f.r. S.p.A.

  lead INDUSTRY

Principal Investigators

• Virginia Ferraresi, MD · IFO Polo Oncologico Ist. Regina Elena, Divisione Oncologia Medica A - ROMA

• Roberto Camerini, MD · Sigma-Tau SpA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-07-31

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• France
• Germany
• Hungary
• Italy
• Poland
• Portugal
• Spain
• Switzerland

Study Locations