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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

November 1, 1999
November 30, 2012
February 1995
July 2003   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002687 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Lymphoma
Biological: aldesleukin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2003
July 2003   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002687
CDR0000064412, UW-24218-A/E, NCI-V95-0758
Not Provided
University of Washington
University of Washington
Not Provided
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