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
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 April 17, 2014