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TerminatedNCT00005788Updated Jun 6, 2012

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

A Phase 2 interventional study of aldesleukin in Lymphoma, sponsored by Northwestern University. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-06.

Sponsored by Northwestern University · Phase 2, Interventional, and Treatment

Why this study was terminated
Low/inadequate rate of accrual.
Phase
Phase 2
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lymphoma

Keywords

  • 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
03

In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

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Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment

Interventions

  • Biologicalaldesleukin
06

Study locations

2 sites
  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
    Chicago, Illinois 60611-3013, United States
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005788
Lead sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 27, 2003
Start date
Apr 1997
Primary completion
Jan 2002
Completion
Jan 2002
Last update
Jun 6, 2012

Study contacts

Timothy M. Kuzel, MD
study chair · Robert H. Lurie Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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