Non Hodgkin Lymphoma Clinical Trial
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin’s Lymphoma or Hodgkin’s Disease
Summary
Phase II trial to study the effectiveness of interleukin-12 in treating patients with previously treated non-Hodgkin's lymphoma or Hodgkin's disease. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill lymphoma cells.
Full Description
PRIMARY OBJECTIVES:
I. Determine the response rate of interleukin-12 in previously treated patients with non-Hodgkin's lymphoma or Hodgkin's disease.
II. To determine the in vivo regulatory effect of interleukin-12 on Fas lingand (FasL) expression on patients' peripheral blood lymphocytes.
OUTLINE: Patients are stratified according to disease characteristics: low grade non-Hodgkin's lymphoma (follicular small cleaved, follicular mixed, small lymphocytic, and variants) versus intermediate grade non-Hodgkin's lymphoma (follicular large, diffuse large, diffuse mixed, immunoblastic, peripheral T-cell, and mantle cell) versus Hodgkin's disease.
Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 36-105 patients will be accrued for this study.
Eligibility Criteria
Inclusion Criteria:
Previously treated non-Hodgkin's lymphoma (all histologies except lymphoblastic and Burkitt's lymphoma) or Hodgkin's disease
Maximum of 4 previous treatment regimens
Measurable disease
No CNS involvement
Performance status - Zubrod 0-1
Performance status - Karnofsky 80-100%
At least 12 weeks
Platelet count at least 75,000/mm^3
Absolute neutrophil count greater than 1500/mm^3
Lymphocyte count greater than 500/mm^3
Hemoglobin at least 8.0 g/dL
Bilirubin less than 1.5 mg/dL
SGOT/SGPT less than 2 times normal
Creatinine no greater than 1.6 mg/dL
Creatinine clearance at least 60 mL/min
No severe cardiovascular disease including active ischemic heart disease, congestive heart failure, or major arrhythmias
No severe pulmonary disease including dyspnea with moderate to severe exertion
HIV negative
No active infection
Not pregnant or nursing
Fertile patients must use adequate contraception
No clinically significant autoimmune disease (e.g. rheumatoid arthritis)
No clinically significant gastrointestinal bleeding or uncontrolled peptic ulcer
No prior allogeneic bone marrow or stem cell transplant
At least 3 weeks since prior biologic therapy for lymphoma
At least 3 weeks since prior chemotherapy for lymphoma
No concurrent steroid therapy
At least 3 weeks since prior endocrine therapy for lymphoma
At least 3 weeks since prior radiotherapy for lymphoma
At least 2 weeks since prior surgery
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There is 1 Location for this study
Houston Texas, 77030, United States
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