Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome

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 lymphoma cells. PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.

Detailed Description
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OBJECTIVES: Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2). Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for survival. PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study.

Official Title
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Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome

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: Histologically proven mycosis fungoides or Sezary syndrome Any stage Measurable disease with 1 or more indicator lesions Evaluable disease for erythrodermic patients only At least 2 weeks since prior therapy, if documented progressive disease (PD) At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.2 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No cardiac pacemaker No clinically significant peripheral venous insufficiency Other: No other malignancy within the past 5 years except: Treated squamous cell or basal cell skin cancer Treated carcinoma in situ of the cervix Surgically treated other cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection HIV negative No poorly controlled diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: No concurrent steroids Radiotherapy: See Disease Characteristics No concurrent radiotherapy Surgery: Not specified Other: No other concurrent proven or investigational antineoplastic therapy

Ages Eligible for Study
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Minimum Age: 18 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 I cutaneous T-cell non-Hodgkin lymphoma, 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 I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome