Interleukin-2 in Treating Patients With Mycosis Fungoides

NCT ID: NCT00002687

Last Updated: 2012-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1995-02-28
• Study Completion Date: 2003-07-31

Brief 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.

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.

Conditions

Lymphoma

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John A. Thompson, MD

Role: STUDY_CHAIR

Seattle Cancer Care Alliance

Locations

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

UW-24218-A/E

Identifier Type: -

Identifier Source: secondary_id

NCI-V95-0758

Identifier Type: -

Identifier Source: secondary_id

CDR0000064412

Identifier Type: -

Identifier Source: org_study_id