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Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome

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ClinicalTrials.gov Identifier: NCT00005788
Recruitment Status : Terminated (Low/inadequate rate of accrual.)
First Posted : January 27, 2003
Last Update Posted : June 6, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Brief Summary:

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells.

PURPOSE: Phase II trial to study the effectiveness of interleukin-2 in treating patients who have mycosis fungoides or Sezary syndrome.


Condition or disease Intervention/treatment Phase
Lymphoma Biological: aldesleukin Phase 2

Detailed Description:

OBJECTIVES:

  • Determine the response rate in patients with mycosis fungoides or Sezary syndrome treated with interleukin-2 (IL-2).
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive interleukin-2 subcutaneously for 4 consecutive days a week for 6 consecutive weeks. Treatment repeats every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response or stable disease continue treatment for 2 courses past best response. Patients who demonstrate a persistent partial response continue treatment in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for survival.

PROJECTED ACCRUAL: A total of 15-35 patients will be accrued for this study.


Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
Study Start Date : April 1997
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002






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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven mycosis fungoides or Sezary syndrome

    • Any stage
  • Measurable disease with 1 or more indicator lesions

    • Evaluable disease for erythrodermic patients only
  • At least 2 weeks since prior therapy, if documented progressive disease (PD)
  • At least 4 weeks since prior therapy, if best response achieved without clear evidence of PD

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute granulocyte count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.2 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No cardiac pacemaker
  • No clinically significant peripheral venous insufficiency

Other:

  • No other malignancy within the past 5 years except:

    • Treated squamous cell or basal cell skin cancer
    • Treated carcinoma in situ of the cervix
    • Surgically treated other cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active infection
  • HIV negative
  • No poorly controlled diabetes mellitus

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • No concurrent steroids

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No other concurrent proven or investigational antineoplastic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005788


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Northwestern University
National Cancer Institute (NCI)
Investigators
Study Chair: Timothy M. Kuzel, MD Robert H. Lurie Cancer Center

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00005788     History of Changes
Other Study ID Numbers: NU 96H7
NU-96H7
NCI-G00-1735
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: May 2012

Keywords provided by Northwestern University:
stage I cutaneous T-cell non-Hodgkin 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 I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
stage III mycosis fungoides/Sezary syndrome
stage IV mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Additional relevant MeSH terms:
Lymphoma
Syndrome
Mycoses
Mycosis Fungoides
Sezary Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Aldesleukin
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents