Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

Inclusion Criteria:

* Histological or cytological diagnosis of cutaneous melanoma and clinical evidence of distant, metastatic, non-resectable regional lymphatic, or extensive in transit recurrent disease
* Patients must have measurable disease; measurable disease is defined as the presence of at least one measurable lesion; if the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology; measurable lesions are defined as lesions that can be accurately measured in at least one dimension with the longest diameter \>= 20 mm using conventional techniques or \>= 10 mm with spiral CT scan

  * Lesions that are considered intrinsically non-measurable include the following:

    * Bone lesions;
    * Leptomeningeal disease;
    * Ascites;
    * Pleural/pericardial effusion;
    * Inflammatory breast disease;
    * Lymphangitis cutis/pulmonis;
    * Abdominal masses that are not confirmed and followed by imaging techniques;
    * Lytic lesions;
    * Lesions that are situated in a previously irradiated area
* No history of peripheral neuropathy, brain metastases or other central nervous system disease
* No history of/active autoimmune disease, hemolytic anemia or concurrent requirement for corticosteroids, including topical or inhaled
* No hepatitis BSAg, known HIV disease or other major active illness; patients with risk factors for HIV should be tested; patients with these illnesses are more likely to experience significant side effects from the study treatment
* No history of severe peptic ulcer disease or gastrointestinal bleeding unless there is objective evidence that the condition is inactive or resolved
* No uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection
* No chemotherapy, radiotherapy, or anti-hormonal therapy within three weeks prior to the initiation of therapy on this study
* No prior therapy with IL-12
* No prior therapy with IFN-alpha for metastatic disease (e.g., biochemotherapy); prior adjuvant therapy with IFN-a is acceptable as long as the patient remained disease-free for 12 months or longer following the last IFN-a treatment
* No prior cytokine therapy for metastatic disease (e.g., high-dose IL-2)
* No more than one prior chemotherapy regimen
* CTC (ECOG) performance status 0-1
* Non-pregnant, non-nursing; treatment under this protocol would expose an unborn child to significant risks; women and men of reproductive potential should agree to use an effective means of birth control; women of child-bearing age will undergo pregnancy testing
* ANC \>= 1500/μL
* Platelets \>= 100,000/μL
* Hemoglobin \> 9 g/dL (may be post transfusion or may receive EPO)
* U-HCG or Serum HCG Negative (if patient of child-bearing potential)