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

Phase 1
18 Years
80 Years
Not Enrolling

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Trial Information

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


- 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

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.

Inclusion Criteria


- 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%



- 18 to 80

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 16 weeks


- 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


- Bilirubin less than 2.5 times normal

- SGOT less than 2.5 times normal


- Creatinine no greater than 2.0 mg/dL

- No nephrotic syndrome


- 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


- See Disease Characteristics

- No dyspnea at rest or severe exertional dyspnea


- No significant CNS dysfunction, including any of the following:

- Seizure disorder

- Active cerebrovascular disease

- Dementia or delirium


- 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


Biologic therapy:

- Not specified


- 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


- At least 4 weeks since prior radiotherapy


- No prior organ allograft

- At least 3 weeks since other prior major surgery


- 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)

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

John A. Thompson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Seattle Cancer Care Alliance


United States: Federal Government

Study ID:




Start Date:

February 1995

Completion Date:

July 2003

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Mycoses
  • Mycosis Fungoides



University of Washington Medical Center Seattle, Washington  98195-6043