This proposal is for New York University Medical Center (NYUMC) to continue to participate as a member of the NCI-sponsored AIDS- associated Malignancies Clinical Trials Consortium (AMC).
The specific aims of this proposal are: 1) To help design, develop and participate in multicenter Phase I and II clinical trials using novel agents and/or innovative approaches for the treatment of patients with AIDS-associated malignancies; 2) To provide well characterized tissue specimens to the recently established AIDS Malignancies Bank (AMB) including: cryopreserved tumor tissue, sera, peripheral blood mononuclear cells (PBMC), bone marrow, and other body fluids from individuals with AIDS-related Neoplasms such as Kaposi's sarcoma (AIDS-KS), non- Hodgkin's lymphoma (NHL), Hodgkin's Disease (HD), multicentric angio- lymphoproliferative hyperplasia (Castleman's Disease), anogenital or cervical dysplasia and carcinomas. These permanently stored specimens would be made available to other members of the AMC and other investigators in the research community at large for future clinical, epidemiologic, virologic and molecular biological research. NYUMC is an NCI-designed Cancer Center. NIAID supported AIDS- Treatment Evaluation Unit (ATEU), and an NIH sponsored Center for AIDS Research (CFAR) to which patients from the greater New York area are referred. NYUMC has served as a major referral center for HIV-infected individuals from the greater New York area. We continue to see a substantial number of patients with AIDS- related malignancies. Investigators at our institution have an established track record for patient accrual and the performance of clinical treatment trials in a well supported setting. Because of the decrease in patients with AIDS-related malignancies seen in the USA, attributed in part to the use of combination, highly active, antiretroviral therapy (HAART), we have recently enlisted the referral of appropriate patients from investigators at Beth Israel and Northshore Hospitals to participate in the AMC trials performed at the NYUMC. A newly formed health management organization (HMO) which will care for more than 10,000 HIV/AIDS clients on Medicaid in NYC has also agreed to refer suitable patients to our AMC clinical trials. Scientists and physicians at NYUMC are dedicated to basic and clinical research on the etiology, pathogenesis and treatment of HIV-disease, especially AIDS-KS, AIDS-NHL and anogenital neoplasia during the past 17 years including participation in the AMC trials since its inception in 1995. These studies have contributed to the development of potentially innovative approaches for the treatment of these neoplastic disorders, which tend to be more aggressive and difficult to manage in AIDS patients.
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