Lymphoma
Conditions
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
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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)
Countries
United States