Interleukin-2 in Treating Patients With Mycosis Fungoides

University of Washington

Status and phase: Completed; Phase 1

Conditions: Lymphoma

Treatments: Biological: aldesleukin

Study type: Interventional

Funder types: Other

Identifiers

NCT00002687

NCI-V95-0758

CDR0000064412

UW-24218-A/E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)