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.

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Biological: aldesleukin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195-6043
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Study Chair: John A. Thompson, MD, Seattle Cancer Care Alliance

Study record dates

Study Major Dates

• Study Start: February 1, 1995
• Primary Completion (Actual): July 1, 2003
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): December 4, 2012
• Last Update Submitted That Met QC Criteria: November 30, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent cutaneous T-cell non-Hodgkin lymphoma; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome; recurrent mycosis fungoides/Sezary syndrome; stage II cutaneous T-cell non-Hodgkin lymphoma; stage II mycosis fungoides/Sezary syndrome
• Additional Relevant MeSH Terms: Infections; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Bacterial Infections and Mycoses; Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma; Mycoses; Mycosis Fungoides; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Antineoplastic Agents; Aldesleukin
• Other Study ID Numbers: CDR0000064412; UW-24218-A/E; NCI-V95-0758