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Phase II Clinical Trial of Interleukin-12 in Patients with Relapsed and Refractory Non-Hodgkin’s Lymphoma and Hodgkin’s Disease

¹ Departments of Lymphoma and Myeloma and ² Diagnostic Radiology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas; ³ Program in Immunology, The University of Texas Graduate School of Biomedical Sciences at Houston, Houston, Texas; ⁴ Department of Hematology/Oncology, Indiana University, Indianapolis, Indiana; and ⁵ Division of Hematologic Malignancies, Johns Hopkins University, Baltimore, Maryland

Purpose: The purpose of this study was to evaluate the clinical activity and toxicity of recombinant human Interleukin (IL)-12 in patients with relapsed and refractory non-Hodgkin’s lymphoma (NHL) or Hodgkin’s disease (HD).

Experimental Design: Forty-two previously treated patients (32 patients with NHL and 10 patients with HD) were enrolled on the study. Patients were treated with either intravenous (n = 11) or subcutaneous (n = 31) administration of IL-12. The patients had received a median of three prior treatment regimens, and 16 patients had undergone prior autologous stem cell transplantation.

Results: All patients were assessable for toxicity, and 39 of 42 (93%) patients were assessable for response. Six of 29 (21%) patients with NHL had a partial or complete response, whereas none of the 10 patients with HD responded. Furthermore, 15 patients had stable disease that lasted for up to 54 months. Progression-free survival in patients with indolent NHL, aggressive NHL, and HD was 6, 2, and 2.5 months, respectively. Treatment was well tolerated, and the most common toxicity was flu-like symptoms. Reversible grade 3 hepatic toxicity was observed in three patients requiring dose reduction. IL-12 therapy increased the median number of peripheral blood CD8 T lymphocytes from 423/µl to 576/µl (P = 0.0019). Furthermore, IL-12 therapy decreased serum vascular endothelial growth factor and basic fibroblast growth factor concentrations in 37% of the patients.

Conclusions: The ability of recombinant human IL-12 therapy to increase the number of circulating CD8+ cells and induce clinical remissions in patients with relapsed NHL warrants further investigation of the drug.

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