Interleukin-2 in Treating Patients With Mycosis Fungoides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00002687
First received: November 1, 1999
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  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 ClinicalTrials.gov identifier: NCT00002687

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

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00002687     History of Changes
Other Study ID Numbers: CDR0000064412, UW-24218-A/E, NCI-V95-0758
Study First Received: November 1, 1999
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

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:
Lymphoma
Mycoses
Mycosis Fungoides
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Aldesleukin
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 21, 2014