Cancer, Skin |
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Clinical Trial: Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
This study is no longer recruiting patients.
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 | Treatment or Intervention | Phase |
|---|---|---|
| Lymphocytic Lymphoma Mycosis Fungoides/Sezary Syndrome Skin Cancer | Drug: interleukin-2 Procedure: biological response modifier therapy Procedure: cytokine therapy Procedure: interleukin therapy | Phase II |
MedlinePlus related topics: Lymphoma; Skin Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Interleukin-2 in Patients With Mycosis Fungoides or Sezary Syndrome
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 above, Genders Eligible for Study: Both
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
Location Information
Illinois
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, 60611-3013, United States
Massachusetts
Boston Medical Center, Boston, Massachusetts, 02118, United States
Timothy M. Kuzel, MD, Study Chair, Robert H. Lurie Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Record last reviewed: April 2003
Last Updated: October 13, 2004
Record first received: June 2, 2000
ClinicalTrials.gov Identifier: NCT00005788
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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