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