Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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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 |
Biological: aldesleukin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome |
| Study Start Date: | April 1997 |
| Study Completion Date: | January 2002 |
| Primary Completion Date: | January 2002 (Final data collection date for primary outcome measure) |
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 |
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| 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 | |
| Study Chair: | Timothy M. Kuzel, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00005788 History of Changes |
| Other Study ID Numbers: | NU 96H7, NU-96H7, NCI-G00-1735 |
| Study First Received: | June 2, 2000 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Mycoses Mycosis Fungoides Sezary Syndrome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, T-Cell, Cutaneous Lymphoma, T-Cell Lymphoma, Non-Hodgkin Aldesleukin |
Interleukin-2 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on May 16, 2013