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

Lymphoma Clinical Trial

Official title:

Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005788
• Other study ID #: NU 96H7
• Secondary ID: NU-96H7NCI-G00-1
• Status: Terminated
• Phase: Phase 2
• First received: June 2, 2000
• Last updated: May 31, 2012
• Start date: April 1997
• Est. completion date: January 2002

Study information

• Verified date: May 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: January 2002
• Est. primary completion date: January 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Mycoses
• Mycosis Fungoides
• Sezary Syndrome

Intervention

Biological:
• aldesleukin

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Robert H. Lurie Comprehensive Cancer Center, Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,