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Blood, 15 June 2006, Vol. 107, No. 12, pp. 4650-4657.
Prepublished online as a Blood First Edition Paper on February 28, 2006; DOI 10.1182/blood-2005-11-4455.
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Submitted November 14, 2005
Accepted February 14, 2006
Activity of subcutaneous interleukin-12 in AIDS-related Kaposi's sarcoma
Richard F Little, James M Pluda, Kathleen M Wyvill, Isaac R Rodriguez-Chavez, Giovanna Tosato, Andrew T Catanzaro, Seth M Steinberg, and Robert Yarchoan*
HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA
Experimental Transplantation and Immunology Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA
Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA
* Corresponding author; email: yarchoan{at}helix.nih.gov.
Interleukin-12 (IL-12) enhances Th1-type T cell responses and exerts anti-angiogenic effects. We initiated a phase 1-pilot study of IL-12 in 32 patients with AIDS-related Kaposi[[rad]]s sarcoma (KS) whose KS was progressing while on antiretroviral therapy. Fifteen patients had poor prognosis T1S1 disease. IL-12 was administered subcutaneously twice weekly at doses from 100 to 625 ng/kg. The maximal tolerated dose was 500 ng/kg, and the principal toxicities were flu-like symptoms, transaminase or bilirubin elevations, neutropenia, hemolytic anemia, and depression. No tumor responses were seen at the lowest dose (100 ng/kg), but 17 of 24 evaluable patients at the higher doses had a partial or complete responses (response rate 71%, 95% confidence interval 48%-89%). Only 3 of 17 patients had a change in antiretroviral therapy before responding, and there were no significant differences between responders and non-responders with regard to changes in CD4 counts or viral loads. Patients had increases in their serum IL-12, interferon- , and inducible protein-10 (IP-10) after the first dose, and increases above baseline persisted after week 4. These results provide preliminary evidence that IL-12 has substantial activity against AIDS-related KS with acceptable toxicity and warrants further investigation for this indication.
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