Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
Interleukin-12 in Treating Patients With Previously Treated Non-Hodgkin's Lymphoma or Hodgkin's Disease
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.
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.
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