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

Primary Purpose

Lymphoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
aldesleukin
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center, Northwestern University
  • Boston Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 2, 2000
Last Updated
May 31, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005788
Brief Title
Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Official Title
Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
Low/inadequate rate of accrual.
Study Start Date
April 1997 (undefined)
Primary Completion Date
January 2002 (Actual)
Study Completion Date
January 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
aldesleukin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy M. Kuzel, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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

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