Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Intervention: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg; Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg; Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg; Dacarbazine + Thymosin-alpha-1 3.2 mg; Dacarbazine + Interferon alpha
Intervention description: 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dacarbazine; Thymalfasin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

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%).
    

Eligibility 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