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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. This Article Full Text Full Text (PDF) All Versions of this Article: 2005-11-4455v1 107/12/4650    most recent Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Little, R. F. Articles by Yarchoan, R. Search for Related Content PubMed PubMed Citation Articles by Little, R. F. Articles by Yarchoan, R. Related Collections Immunobiology Neoplasia Chemokines, Cytokines, and Interleukins Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Activity of subcutaneous interleukin-12 in AIDS-related Kaposi 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 From the HIV and AIDS Malignancy Branch, the Experimental Transplantation and Immunology Branch, and the Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, MD. Interleukin-12 (IL-12) enhances Th1-type T-cell responses and exerts antiangiogenic effects. We initiated a phase 1 pilot study of IL-12 in 32 patients with acquired immunodeficiency syndrome (AIDS)–related Kaposi 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 maximum tolerated dose was 500 ng/kg, and the principal toxicities were flulike 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 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 nonresponders 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. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: R. F. Little, K. Aleman, P. Kumar, K. M. Wyvill, J. M. Pluda, E. Read-Connole, V. Wang, S. Pittaluga, A. T. Catanzaro, S. M. Steinberg, et al. Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma Blood, December 15, 2007; 110(13): 4165 - 4171. [Abstract] [Full Text] [PDF] M. Del Vecchio, E. Bajetta, S. Canova, M. T. Lotze, A. Wesa, G. Parmiani, and A. Anichini Interleukin-12: Biological Properties and Clinical Application Clin. Cancer Res., August 15, 2007; 13(16): 4677 - 4685. [Abstract] [Full Text] [PDF]

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