The Mount Sinai Medical Center is applying as a Clinical Trials Member of the AIDS-associated Malignancies Clinical Trials Consortium. With our experience as a member of the AIDS Clinical Trials Group (ACTG), we have demonstrated in its ability to generate protocols and contribute to the AIDS oncology scientific agenda, to recruit a diverse patient population with HIV infection, coordinate data and specimen collection, perform virologic and immunologic evaluations as well as pharmacokinetic studies, collect and report high quality clinical and laboratory data, and collaborate with NIH and other institutions involved in adult and pediatric trials. For this Clinical Trials Member, we are teaming with Beth Israel Medical Center, who is also our partner in the ACTU. In addition, we have formed a network with Cabrini Medical Center, Bronx Veterans Administration Hospital, Elmhurst Hospital Center and Queens Hospital enter which will contribute patients for this clinical trials Consortium. Advanced and complicated protocols from this consortium will be performed in the GCRC at Mount Sinai Medical Center. With this setup, we propose to accrue and retain a minimum of 30 patients per year in Clinical Trials of the Consortium. The uniqueness of our application is that i) we have a large number of HIV-infected women and minority persons (these groups are traditionally underrespresented in most of the clinical trials). Based on data in the ACTG nationwide database as of 12/16/94, our unit was first in enrollment of patients with a history of IV drug use, second in the number of Hispanics, third,in total number of women enrolled, and fourth in number of Blacks enrolled of all ACTUs across the country. ii) we are becoming an expert of tumor angiogenesis inhibitor and we have commitment from Dr. Hellerqvist to study CM101 (a group B Streptococcus toxin) in our medical center. We are proposing a phase I-II protocol of CM 101 to be studied in the Consortium, ii) Dr. Mary Klotman's expertise on antisense compounds would assist us to develop antisense compounds , such as anti-fibroblast growth factor (FGF) , for treatment of Kaposi's sarcoma. By capitalizing on the investigative strengths of our multidisciplinary research team, recruited from within our institution, we also propose to contribute to the design and conduct trials that will explore the pathogenesis of HIV-related malignancies.
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