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Home > "I" Clinical Trials Conditions > Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome  Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
For Condition: Lymphocytic Lymphoma,Mycosis Fungoides/Sezary Syndrome,Skin Cancer
Status: No longer recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyKuzel, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Additional Information:
Study ID Numbers: CDR0000067726; NU-96H7,NCI-G00-1735
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005788
Other Skin Cancer Studies:
1. High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Advanced Cancer
2. Phase II Trial of Allovectin-7® for Metastatic Melanoma
3. Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
4. Study of Talabostat in Advanced Melanoma
5. Study of Talabostat and Cisplatin in Advanced Melanoma
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Interleukin-2 in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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