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

Phase 2TerminatedNCT00005788

Northwestern University

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lymphoma

Interventions

aldesleukinBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, United States

Boston Medical Center

Boston, Massachusetts, United States

Data from ClinicalTrials.gov

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