The Memorial Sloan-Kettering Cancer Center is applying to become a Clinical Trials Member of the AIDS-Associated Malignancies Clinical Trials Consortium. Our qualifications include: (1) Broad expertise in the development and performance of innovative clinical trials in a wide spectrum of AIDS-associated malignancies and other clinical and laboratory investigations relevant to future development of novel phase 1-11 trials; (2) Expertise in infectious diseases required for the care of patients with AIDS-associated malignancies; (3) An extensive institutional and community-based referral network that will facilitate the accrual of a sufficient number of patients with AIDS-associated malignancies to meet the enrollment goals of consortium-sponsored trials; (4) A well-developed clinical, laboratory and data management infrastructure to support patient care, data collection and quality control monitoring, and resources to support the collection of tumor tissue and biological fluids for the Tissue and Biological Fluid Banks of AIDS-Associated Malignancies; and (5) a proven record of participation and leadership in cooperative group and industrial- and NCI-sponsored trials. Particular strengths of our group include: extensive experience in the early phase testing and evaluation of cytokines and cytokine modulators in cancer and AIDS, with an emphasis on Kaposi's sarcoma; an active program for development and diagnostic and therapeutic applications of monoclonal antibodies in cancer including AIDS-associated non-Hodgkin's lymphoma; experience in adoptive immunotherapy for EBV-associated NHL; an active gene therapy program; expertise in the development of novel therapeutic approaches for primary CNS lymphomas; expertise in the design, performance and analysis of phase I drug trials including pharmacokinetic sampling and analytic capabilities; and, experience in the diagnosis, treatment and clinical and laboratory monitoring of patients with human papillomavirus-associated anogenital squamous malignancies. This experience has been used to develop concepts for several innovative clinical trials for AIDS-associated malignancies that could be considered for implementation through the Consortium. In sum, our scientific and clinical resources make us uniquely positioned to contribute to a collaborative clinical trials effort for AIDS-associated malignancies and to the development of an innovative research agenda for the group.
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