Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides

Inclusion Criteria

• •Histologically confirmed mycosis fungoides
• •* Stage Ib-IV
• •At least 5% of total blood mononuclear cells must be CD8-positive lymphocytes
• •No CNS disease
• •Performance status - Karnofsky 70-100%
• •At least 6 months
• •WBC ≥ 3,000/mm\^3 but ≤ 40,000/mm\^3
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Hemoglobin ≥ 10 g/dL (transfusion or epoetin alfa allowed)
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST and ALT ≤ 2 times ULN
• •Creatinine ≤ 1.5 times ULN
• •Creatinine clearance ≥ 60 mL/min
• •EKG normal
• •No known cardiac and peripheral vascular disease
• •No cardiac arrhythmias requiring medical treatment
• •Chest x-ray normal
• •No history of or clinically significant autoimmune disease (e.g., rheumatoid arthritis), autoimmune hemolytic anemia, or positive Coombs' test
• •No HTLV-I or HTLV-II-associated disease
• •HIV negative
• •Antinuclear antibody negative
• •Rheumatoid factor negative
• •No serious concurrent infection requiring IV antibiotics
• •No clinically significant gastrointestinal bleeding
• •No uncontrolled peptic ulcer disease
• •No history of inflammatory bowel disease
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No history of peripheral neuropathy
• •No other major illness that would substantially increase the patient's risk
• •Prior interferon allowed
• •Prior denileukin diftitox allowed
• •No prior interleukin (IL)-2 or IL-12
• •No prior anti-T-cell monoclonal antibody therapy
• •No other concurrent biologic therapy
• •Prior topical imidazole mustard or carmustine allowed
• •Prior bexarotene allowed
• •Prior oral methotrexate allowed
• •At least 3 weeks since prior topical chemotherapy
• •At least 8 weeks since prior treatment with any single chemotherapeutic agent (12 weeks for multiple chemotherapeutic agents)
• •* Treatment must not have included steroids
• •No prior systemic chemotherapy
• •No prior fludarabine, pentostatin, or cladribine
• •No concurrent systemic chemotherapy
• •At least 3 weeks since prior topical or systemic steroids more potent than 1% hydrocortisone
• •No concurrent systemic corticosteroids
• •No concurrent low-potency steroid creams
• •No concurrent radiotherapy
• •Not specified
• •At least 3 weeks since prior psoralen-ultraviolet-light (PUVA) or ultraviolet B (UVB)
• •At least 3 weeks since prior retinoids
• •At least 3 weeks since prior investigational drugs
• •Prior photopheresis allowed
• •No other concurrent investigational therapy