Interleukin-2 in Treating Patients With Mycosis Fungoides

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Biological: aldesleukin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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