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.
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.
- 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