Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma

Richard F. Little, Karen Aleman, Pallavi Kumar, Kathleen M. Wyvill, James M. Pluda, Elizabeth Read-Connole, Victoria Wang, Stefania Pittaluga, Andrew T. Catanzaro, Seth M. Steinberg, Robert Yarchoan

Research output: Contribution to journalArticle


Thirty-six patients with AIDS-associated Kaposi sarcoma (KS) requiring chemotherapy were treated for six 3-week cycles of pegylated liposomal doxorubicin (20 mg/m2) plus interleukin-12 (IL-12; 300 ng/kg subcutaneously twice weekly), followed by 500 ng/kg subcutaneous IL-12 twice weekly for up to 3 years. All received highly active antiretroviral therapy (HAART). Twenty-two had poor-prognosis KS (T1S1). Thirty patients had a major response, including 9 with complete response, yielding an 83.3% major response rate (95% confidence interval: 67.2%-93.6%). Median time to first response was 2 cycles. Median progression was not reached at median potential follow-up of 46.9 months. Of 27 patients with residual disease when starting maintenance IL-12, 15 had a new major response compared with this new baseline. The regimen was overall well tolerated; principal toxicities were neutropenia, anemia, transaminitis, and neuropsychiatric toxicity. Patients had increases in serum IL-12, interferon gamma, and inducible protein-10 (IP-10), and these remained increased at weeks 18 and 34. The regimen of IL-12 plus liposomal doxorubicin yielded rapid tumor responses and a high response rate in patients with AIDS-KS receiving HAART, and responses were sustained on IL-12 maintenance therapy. A randomized trial of IL-12 in this setting may be warranted. This study is registered at as no. NCT00020449.

Original languageEnglish (US)
Pages (from-to)4165-4171
Number of pages7
Issue number13
StatePublished - Dec 15 2007


ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

Cite this

Little, R. F., Aleman, K., Kumar, P., Wyvill, K. M., Pluda, J. M., Read-Connole, E., Wang, V., Pittaluga, S., Catanzaro, A. T., Steinberg, S. M., & Yarchoan, R. (2007). Phase 2 study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi sarcoma. Blood, 110(13), 4165-4171.