Search / Trial NCT00002687

Interleukin-2 in Treating Patients With Mycosis Fungoides

Launched by UNIVERSITY OF WASHINGTON · Jan 26, 2003

Trial Information

Current as of November 03, 2024

Completed

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

ClinConnect Summary

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 maximu...

Gender

ALL

Eligibility 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)

About University Of Washington

The University of Washington (UW) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust network of interdisciplinary teams, UW fosters collaboration among top-tier researchers, clinicians, and healthcare professionals, aiming to translate scientific discoveries into impactful treatments and interventions. The university is dedicated to ethical research practices and participant safety, ensuring rigorous adherence to regulatory standards in all clinical trials. Through its state-of-the-art facilities and extensive expertise, UW strives to address pressing health challenges and improve patient outcomes on a local and global scale.

Locations

Seattle, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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