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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005788
  Purpose

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 Intervention Phase
Lymphoma
Drug: aldesleukin
Phase II

MedlinePlus related topics:   Cancer    Fungal Infections    Lymphoma   

Drug Information available for:   Aldesleukin    Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   February 2000

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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
Robert H. Lurie Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Timothy M. Kuzel, MD     Robert H. Lurie Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067726, NU-96H7, NCI-G00-1735
First Received:   June 2, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00005788
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Aldesleukin
Interleukin-2
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Anti-Infective Agents
Anti-HIV Agents
Neoplasms by Histologic Type
Disease
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Antiviral Agents
Pharmacologic Actions
Neoplasms
Pathologic Processes
Anti-Retroviral Agents
Analgesics, Non-Narcotic
Sensory System Agents
Syndrome
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2008




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