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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Recombinant Human Interleukin-12 (rhIL-12) for the Treatment of Relapsed Lymphoma and Hodgkin's Disease

Conditions
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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

Intervention / Treatment
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* Biological: recombinant interleukin-12
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (interleukin-12)<br>Patients receive interleukin-12 subcutaneously twice a week. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. | Biological: recombinant interleukin-12<br>* Given subcutaneously<br>* Other names: Ro 24-7472;Other: laboratory biomarker analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | Simon's two-stage model will be used. | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by CTC version 2.0 |  | Up to 5 years after completion of study treatment |