PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Intervention: PEG-interferon alfa-2b
Intervention description: Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent melanoma; stage IV melanoma

Summary:

      RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping
      blood flow to the tumor.

      PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating
      patients who have stage IV melanoma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed stage IV melanoma

               -  Stage M1a, M1b, or M1c

               -  Mucosal, ocular, or unknown primary melanoma

          -  Previously untreated OR received up to 3 prior systemic therapy regimens (excluding
             vaccine therapy) for metastatic disease

          -  Plasma basic fibroblast growth factor level at least 15 pg/mL

          -  Measurable or evaluable disease

          -  Central nervous system (CNS) involvement allowed provided CNS directed therapy has
             been given and disease has been clinically stable for ≥ 3 months

               -  Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to
                  confirm stable disease required ≤ 4 weeks prior to study entry

          -  Age: 18 and over

          -  ECOG Performance status of 0-2

          -  Life expectancy at least 6 months

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

          -  Hemoglobin at least 8 g/dL (transfusions allowed)

          -  Bilirubin no greater than 2 times upper limit of normal (ULN)

          -  Alanine Aminotransferase (ALT) no greater than 2 times ULN

          -  Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min

          -  At least 4 weeks since prior interferon in the adjuvant or metastatic setting

          -  At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting

          -  At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting

          -  At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting

          -  At least 4 weeks since prior surgery in the adjuvant or metastatic setting

          -  At least 4 weeks since other prior therapy in the adjuvant or metastatic setting

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

        Exclusion criteria:

          -  Myocardial infarction within the past 6 months

          -  Other active malignancy within the past 5 years except curatively treated basal cell
             or squamous cell skin cancer or carcinoma in situ of the cervix

          -  Other concurrent illness that would preclude study participation

          -  History of severe depression

          -  Pregnant or nursing