interleukin-2 in treating patients with mycosis fungoides

Conditions: Lymphoma

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill cancer cells. purpose: phase i trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides.

objectives: * determine the maximum tolerated dose and toxicity of interleukin-2 in patients with stage iib-iv mycosis fungoides. * determine the response rate of patients treated with this regimen. * determine the immunologic response to this regimen in peripheral blood leukocytes and serum of these patients. outline: this is a dose escalation study. patients receive interleukin-2 (il-2) subcutaneously on days 1-5 during weeks 1-3 and on days 1-3 and 5 during week 4. treatment repeats every 4 weeks for 4 courses. cohorts of 3-6 patients receive escalating doses of il-2 until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose at which 3 of 6 patients experience dose-limiting toxicity. six additional patients receive il-2 at 1 dose level preceding the mtd. patients are followed at least 3 times during year 1 and then annually thereafter. projected accrual: a total of 16-30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * clinically and histologically proven diagnosis of 1 of the following: * mycosis fungoides (mf) meeting 1 of the following conditions: * stage iib disease that has failed psoralen ultraviolet a (puva) light therapy and topical chemotherapy (mechlorethamine and/or carmustine) * stage iii disease with generalized erythroderma * stage iv disease with biopsy proven nodal or visceral involvement * sezary syndrome * stage iii mf with a minimum of 20% sezary cells (based on total wbc) * no clinically significant ascites or pleural effusion * clinically significant pleural effusion defined as shortness of breath with oxygen saturation less than 90% patient characteristics: age: * 18 to 80 performance status: * karnofsky 70-100% life expectancy: * at least 16 weeks hematopoietic: * see disease characteristics * wbc at least 3,500/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hemoglobin at least 11.5 g/dl hepatic: * bilirubin less than 2.5 times normal * sgot less than 2.5 times normal renal: * creatinine no greater than 2.0 mg/dl * no nephrotic syndrome cardiovascular: * no history of myocardial infarction or congestive heart failure * no symptomatic coronary artery disease * no clinically manifest hypotension * no severe hypertension * no arrhythmia on electrocardiogram * no edema * no contraindication to pressor agents pulmonary: * see disease characteristics * no dyspnea at rest or severe exertional dyspnea neurologic: * no significant cns dysfunction, including any of the following: * seizure disorder * active cerebrovascular disease * dementia or delirium other: * no autoimmune disease, including psoriasis * no uncontrolled peptic ulcer disease * no uncontrolled infection * no history of adverse reaction to interleukin-2 * hiv and htlv-i negative * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior systemic or topical chemotherapy (6 weeks since prior mitomycin or nitrosoureas) endocrine therapy: * at least 1 week since prior corticosteroids * no concurrent corticosteroids radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * no prior organ allograft * at least 3 weeks since other prior major surgery other: * at least 4 weeks since prior immunosuppressive therapy * at least 2 weeks since prior phototherapy (ultraviolet b \[uvb\] or puva light therapy) * no concurrent phototherapy (uvb or puva light therapy)

Keywords: stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma stage ii mycosis fungoides/sezary syndrome stage iii mycosis fungoides/sezary syndrome stage iv mycosis fungoides/sezary syndrome recurrent mycosis fungoides/sezary syndrome