Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia
Conditions
Brief 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.
Detailed 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.
Interventions
BIOLOGICALrecombinant interleukin-12
Given subcutaneously
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | Up to 5 years | Simon's two-stage model will be used. |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity as assessed by CTC version 2.0 | Up to 5 years after completion of study treatment |
Countries
United States
Outcome results
None listed