NYUMC-AIDS-RELATED MALIGNANCY CONSORTIUM

这项提案是为了让纽约大学医学中心(NYUMC)继续作为NCI赞助的艾滋病相关恶性肿瘤临床试验联盟(AMC)的成员参加。这项建议的具体目标是：1)帮助设计、开发和参与多中心第一阶段和第二阶段临床试验，使用新的药物和/或创新方法治疗艾滋病相关恶性肿瘤患者；2)为最近成立的爱滋病恶性病库(AMB)提供有特色的组织样本，包括：冷冻保存的肿瘤组织、血清、外周血单核细胞(PBMC)、骨髓和其他患有艾滋病相关肿瘤的个体的体液，如卡波西肉瘤(AIDS-KS)、非霍奇金淋巴瘤(NHL)、霍奇金病(HD)、多中心血管淋巴增生性增生(Castleman病)、肛门或宫颈发育不良和癌症。这些永久保存的标本将提供给AMC的其他成员和研究界的其他研究人员，用于未来的临床、流行病学、病毒学和分子生物学研究。NYUMC是NCI设计的癌症中心。NIAID支持艾滋病治疗评估单位(ATEU)，以及NIH赞助的艾滋病研究中心(CFAR)，来自大纽约地区的患者被转介到该中心。NYUMC一直是来自大纽约地区的艾滋病毒感染者的主要转诊中心。我们继续看到相当数量的艾滋病相关恶性肿瘤患者。我们机构的研究人员在一个得到良好支持的环境下，有关于患者收益和临床治疗试验表现的既定记录。由于美国艾滋病相关恶性肿瘤患者的减少，部分归因于联合、高效、抗逆转录病毒疗法(HAART)的使用，我们最近从贝丝以色列医院和Northshore医院的研究人员那里转介了合适的患者参加在NYUMC进行的AMC试验。一个新成立的健康管理组织(HMO)将在纽约市为10,000多名艾滋病毒/艾滋病患者提供医疗补助，该组织也同意将合适的患者转介到我们的AMC临床试验。纽约大学医学院的科学家和医生在过去的17年里致力于艾滋病毒疾病的病原学、发病机制和治疗的基础和临床研究，特别是艾滋病-KS、艾滋病-非霍奇金淋巴瘤和肛门生殖系统肿瘤，包括自1995年AMC试验以来参与的研究。这些研究有助于开发潜在的创新方法来治疗这些肿瘤疾病，这些疾病在艾滋病患者中往往更具侵略性，更难管理。

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.