Interleukin-2 in Treating Patients With Mycosis Fungoides

Lymphoma Clinical Trial

Official title:

Phase 1 Trial of Subcutaneous [SC]; Outpatient Interleukin-2 for Patients With Advanced Mycosis Fungoides [Stage IIb, III, IV]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002687
• Other study ID #: CDR0000064412
• Secondary ID: UW-24218-A/ENCI-
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: November 30, 2012
• Start date: February 1995
• Est. completion date: July 2003

Study information

• Verified date: November 2012
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States,