Fotemustine and Dacarbazine Versus Dacarbazine +/- Alpha Interferon in Advanced Malignant Melanoma
Condition: Malignant Melanoma; Recurrent Melanoma
MeSH terms: Melanoma
Intervention: Dacarbazine; Fotemustine; Interferon Alfa-2b
Intervention description: 900 mg / m2 every 3 weeks; 100 mg / m2 every 3 weeks; 5 M units every 3 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dacarbazine; Fotemustine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study evaluated two chemotherapy regimens with and without the addition of interferon in
      patients with advanced or recurrent melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of malignant melanoma in advanced stage or
             recurrent after surgery, and not amenable to further surgery or local therapy.

          -  Presence of measurable disease

          -  Age > or = 18 years and < or = 75 years

          -  Performance status (ECOG) 0 - 2 (Appendix 2)

          -  Life expectancy ³ 3 months

          -  Adequate bone marrow function (ANC ³ 2,000/mmc; PTL ³ 100,000/mmc; Hb ³ 10 gr/dl),
             normal liver and renal function (bilirubin < 1.25 x N, creatinine < 1.25 x N, SGOT,
             SGPT < 3 times upper normal limit of testing laboratory.

          -  Written, informed consent prior to study specific procedures, with the understanding
             that the patient has the right to withdraw from the study at any time, without
             prejudice.

          -  Prior surgery > 3 weeks from initiating .

          -  If palliative radiation is needed, in case of non target lesions, it must be given
             prior to initiating chemotherapy. If palliative radiation is required during the study
             the patient should be permanently discontinued from further treatment.

          -  Adequate contraceptive measures during study participation for sexually active
             patients of child bearing potential must implement.

        Exclusion Criteria:

          -  Previous or concurrent malignancies at other sites with the exception of surgically
             cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the
             skin.

          -  Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed)

          -  Known HIV disease.

          -  Concurrent treatment with other experimental drugs.

          -  Concurrent chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and
             replacement steroids), radiation therapy

          -  Pregnant or lactating females Previous or concurrent malignancies at other sites with
             the exception of surgically cured carcinoma in-site of the cervix and basal or
             squamous cell carcinoma of the skin.

        Prior chemo-immunotherapy ( previous adjuvant immunotherapy is allowed) Known HIV disease.
        Concurrent treatment with other experimental drugs. Concurrent chemotherapy, immunotherapy,
        hormonal therapy (excluding contraceptives and replacement steroids), radiation therapy