Interleukin-2 in Treating Patients With Mycosis Fungoides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002687
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 4, 2012
Information provided by (Responsible Party):
University of Washington

November 1, 1999
January 27, 2003
December 4, 2012
February 1995
July 2003   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002687 on Archive Site
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Interleukin-2 in Treating Patients With Mycosis Fungoides
Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]

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.


  • 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.

Phase 1
Primary Purpose: Treatment
Biological: aldesleukin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2003
July 2003   (Final data collection date for primary outcome measure)


  • 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%



  • 18 to 80

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 16 weeks


  • 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


  • Bilirubin less than 2.5 times normal
  • SGOT less than 2.5 times normal


  • Creatinine no greater than 2.0 mg/dL
  • No nephrotic syndrome


  • 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


  • See Disease Characteristics
  • No dyspnea at rest or severe exertional dyspnea


  • No significant CNS dysfunction, including any of the following:

    • Seizure disorder
    • Active cerebrovascular disease
    • Dementia or delirium


  • 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


Biologic therapy:

  • Not specified


  • 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


  • At least 4 weeks since prior radiotherapy


  • No prior organ allograft
  • At least 3 weeks since other prior major surgery


  • 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)
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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University of Washington
University of Washington
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Study Chair: John A. Thompson, MD Seattle Cancer Care Alliance
University of Washington
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP