Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Eligibility Criteria
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
Sites / Locations
- Abramson Cancer Center of The University of Pennsylvania
Arms of the Study
Arm 1
Experimental
Treatment (aldesleukin, recombinant interleukin-12)
Patients receive IL-12 SC twice weekly for 24 weeks. Disease is assessed at 13 weeks. Patients who do not have progressive disease also receive IL-2 SC 3 consecutive days a week during weeks 13-24. Patients with progressive disease at week 13 receive IL-2 SC at a fixed dose during weeks 13-24. Patients with responding disease after week 24 may continue to receive IL-2 and IL-12 for another 12 weeks. Cohorts of 3-6 patients receive escalating doses of IL-2 until the MTD is determined. The MTD is defined as the dose at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. The RD is the dose preceding the MTD. Additional patients are treated at the RD.