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

NCT00005788 | Terminated Phase 2 DMC

• 3 other identifiers: NU 96H7NU-96H7NCI-G00-1735
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Interventions

aldesleukin BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Study Officials

• Timothy M. Kuzel, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: January 27, 2003
• Study Start: April 1, 1997
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: June 6, 2012

Record last verified: 2012-05

Locations

US (2)