Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the Sezary Syndrome
18 Years
N/A
Both
Lymphoma
Trial Information
Phase II Trial of Subcutaneous Injections of Interleukin-2 for the Treatment of Mycosis Fungoides or the 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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Timothy M. Kuzel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 96H7
NCT ID:
NCT00005788
Start Date:
April 1997
Completion Date:
January 2002
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |
| Boston Medical Center | Boston, Massachusetts 02118 |
