Phase II trial to study the effectiveness of combining interleukin-12 and interferon alfa in
treating patients who have metastatic malignant melanoma. Interleukin-12 may kill tumor
cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to
kill cancer cells. Interferon alfa may interfere with the growth of the cancer cells.
Combining interleukin-12 and interferon alfa may kill more tumor cells.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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)