Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]

Date de début de l'étude : 1 février 1995

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)