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)