This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Interleukin-2 in Treating Patients With Mycosis Fungoides

This study has been completed.
Information provided by (Responsible Party):
University of Washington Identifier:
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Lymphoma Biological: aldesleukin Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]

Resource links provided by NLM:

Further study details as provided by University of Washington:

Estimated Enrollment: 30
Study Start Date: February 1995
Study Completion Date: July 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002687

United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Sponsors and Collaborators
University of Washington
Study Chair: John A. Thompson, MD Seattle Cancer Care Alliance
  More Information

Responsible Party: University of Washington Identifier: NCT00002687     History of Changes
Other Study ID Numbers: CDR0000064412
Study First Received: November 1, 1999
Last Updated: November 30, 2012

Keywords provided by University of Washington:
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

Additional relevant MeSH terms:
Mycosis Fungoides
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Antineoplastic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on September 19, 2017