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: 0
• Participant gender: All

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%).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: sigma-tau i.f.r. S.p.A.
• Treatments: Dacarbazine; Interferon alpha-2; Interferon-alpha; Interferons; Thymalfasin

Criteria

Inclusion Criteria:

• Have read and signed the informed consent form

• 18 years <=Age<= 75 years

• Adequate contraception practice (fertile female patient)

• Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases and >= 1 measurable lesion

• Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/deciliter (dl)

• Absolute Neutrophil Count (ANC) >= 1.5 x 10000000000/L ; platelets >= 100 x 10000000000/Liter (L)

• Good performance status: PS <= 1 (ZUBROD-ECOG-WHO scale)

• At least 12 week life expectancy

Exclusion Criteria:

• Clinical diagnosis of autoimmune disease

• Transplant recipient

• Pregnancy documented by a urine pregnancy test or lactation

• Previous treatment with thymosin alpha 1

• Previous treatment with chemotherapy

• Presence of Central Nervous System (CNS) metastases

• Concomitant or prior history of malignancy other than melanoma

• Participation in another investigational trial within 30 days of study entry

• Active infectious process that is not of self-limiting nature