This application is a five year competing renewal for the AIDS Malignancy Consortium (AMC) grant currently awarded to Michael A. Caligiuri, M.D. at The Ohio State University (OSU). During the past four years of this award, the PI was an active participant in the AMC Lymphoma Working Group and the AMC Laboratory Working Group. The PI successfully competed for correlative science awards for two AMC clinical trials, and the PI currently chairs one AMC clinical protocol that uses a biologic response modifier in HIV non Hodgkin's lymphoma (NHL). Two additional clinical studies are currently under development by the PI for the AMC: The first is a randomized trial of low dose interleukin (IL) 2 following first induction therapy in HIV NHL. This study will likely be performed in collaboration with industry and AIDS malignancy sites in Europe. The letter of intent (LOI) was reviewed by the AMC and a protocol has been submitted to the AMC. The second study submitted by the PI is a phase II study assessing the anti-tumor activity of anti-CD20 monoclonal antibody against patients with posttransplant lymphoproliferative disorder (PTLD). PTLD will now be incorporated into the AMC agenda as an immunodeficiency lymphoma, and this will be the first such protocol within the AMC. The LOI as been approved by the AMC and the protocol has been submitted. Despite these intellectual contributions, the accrual of OSU and its former affiliate, Roswell Park Cancer Institute, was poor, ranking approximately 8th among 13 primary AMC sites. Therefore, in order to address this weakness, the PI has now affiliated with four new sites, each with a high patient volume of HIV-1+ patients and patients with AIDS malignancies, and each a new member to the AMC. The PI is no longer affiliating with Roswell Park. These four new sites include the University of Maryland Cancer Center, The Brady Memorial Hospital of Emory University, Saint Vincent's Comprehensive Cancer Center in New York, and a consortium of three hospitals in Australia that function under a common clinical research group called the National Center for HIV Epidemiology and Clinical Research (NCHECR). The NCHECR evaluates and treats the vast majority of HIV-1 and AIDS malignancy patients for all of Australia. Each of the OSU- affiliated sites has unique strengths. Some centers have large inner city populations with high volumes of women and minority patients, while other centers have extremely strong histories of phase I-III cooperative group trials or unique laboratory expertise. Collectively, this new group of OSU-affiliated sites should bring several strengths to the AMC, most notably an increase in accrual to AMC protocols for HIV NHL and HIV Kaposi's sarcoma. A budget has been structured to provide a minimal baseline of support for each affiliated site to get protocols approved by Institutional Review Boards and to begin to screen patients for study. However, after an initial accrual of four patients per site, the funding of each site becomes tied to their ability to accrue patients. Collectively, this application provides enhanced strength in intellectual contributions and patient accrual for the AMC, compared to our previous application.

National Institute of Health (NIH)
National Cancer Institute (NCI)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZCA1-SRRB-Y (M1))
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Bhatia, Kishor
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Ohio State University
Internal Medicine/Medicine
Schools of Medicine
United States
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Lin, Lan; Lee, Jeannette Y; Kaplan, Lawrence D et al. (2009) Effects of chemotherapy in AIDS-associated non-Hodgkin's lymphoma on Kaposi's sarcoma herpesvirus DNA in blood. J Clin Oncol 27:2496-502
Brinker, Brett T; Krown, Susan E; Lee, Jeannette Y et al. (2008) Phase 1/2 trial of BMS-275291 in patients with human immunodeficiency virus-related Kaposi sarcoma: a multicenter trial of the AIDS Malignancy Consortium. Cancer 112:1083-8
Dezube, Bruce J; Krown, Susan E; Lee, Jeannette Y et al. (2006) Randomized phase II trial of matrix metalloproteinase inhibitor COL-3 in AIDS-related Kaposi's sarcoma: an AIDS Malignancy Consortium Study. J Clin Oncol 24:1389-94
Shah, Manisha H; Freud, Aharon G; Benson Jr, Don M et al. (2006) A phase I study of ultra low dose interleukin-2 and stem cell factor in patients with HIV infection or HIV and cancer. Clin Cancer Res 12:3993-6
Kaplan, Lawrence D; Lee, Jeannette Y; Ambinder, Richard F et al. (2005) Rituximab does not improve clinical outcome in a randomized phase 3 trial of CHOP with or without rituximab in patients with HIV-associated non-Hodgkin lymphoma: AIDS-Malignancies Consortium Trial 010. Blood 106:1538-43
Noy, Ariela; Scadden, David T; Lee, Jeannette et al. (2005) Angiogenesis inhibitor IM862 is ineffective against AIDS-Kaposi's sarcoma in a phase III trial, but demonstrates sustained, potent effect of highly active antiretroviral therapy: from the AIDS Malignancy Consortium and IM862 Study Team. J Clin Oncol 23:990-8
Shah, Manisha H; Porcu, Pierluigi; Mallery, Susan R et al. (2003) AIDS-associated malignancies. Cancer Chemother Biol Response Modif 21:717-46
Miles, Steven A; Dezube, Bruce J; Lee, Jeannette Y et al. (2002) Antitumor activity of oral 9-cis-retinoic acid in HIV-associated Kaposi's sarcoma. AIDS 16:421-9
Shah, Manisha H; Porcu, Pierluigi; Mallery, Susan R et al. (2002) AIDS-associated malignancies. Cancer Chemother Biol Response Modif 20:633-64
Khatri, V P; Baiocchi, R A; Bernstein, Z P et al. (1997) Immunotherapy with low-dose interleukin-2: rationale for prevention of immune-deficiency-associated cancer. Cancer J Sci Am 3 Suppl 1:S129-36