The Southern California AMC Consortium application has the following alms: (1) To help design, develop and conduct collaborative, innovative Phase I and II clinical trials, employing novel agents and approaches in patients with various AIDS related malignancies, and to assure timely completion of these trials. (2) To assure accrual of 30 or more patients per year to these clinical trials; (3) To assure adequate accrual of women and minorities to these innovative clinical trials; (4) To provide tumor tissue and other relevant biologic materials, derived from patients accrued onto AMC trials; (5) To share the experience and expertise of our faculty with that of other Consortium members; and (6) To develop and conduct larger national or international randomized clinical trials in treatment and/or prevention should relevant questions arise. The AIDS Malignancy Program at USC School of Medicine has been extremely active and productive since the beginning of the AIDS epidemic, having published a total of 374 manuscripts and abstracts (average of 25/year) since 1984, related to HIV and AIDS-malignancies. Our group has completed a total of 51 phase I/II studies for patients with AIDS-malignancy during this period, resulting in 32 manuscripts and 56 abstracts. An additional 5 phase III protocols resulted in 3 manuscripts and 7 abstracts. We have been instrumental in developing innovative therapies, such as anti-angiogenesis compounds, liposomal drugs, monoclonal antibodies and conjugates, and anti-sense oligos. LA County-USC Medical Center serves a largely indigent, minority patient population. From 1990-1998, the accrual of minority patients to AIDS-malignancy trials has ranged from 38 percent (1990) to 62 percent (1998). The presence of an NIH sponsored Women's Interagency HIV Study (WIHS) at USC, under the direction of the PI on the current proposal, provides potential access to AMC trials for the 535 women who are followed each 6 months as part of the WIHS. Our commitment to the AIDS Malignancy Bank may be seen by the fact that our group has already donated 4,024 tissue specimens to the Bank as of 10/l/98; we will continue this commitment. Our group has entered 11 patients to current AMC trials, with difficulties related to the fact that 2 of 5 available protocols required specific anti-retroviral regimens, in addition to other eligibility requirements. Other difficulties included lack of truly innovative protocols available for KS; decreasing numbers of patients with KS in the USA; and the difficult financial environment in the LA area in terms of managed care. In the current application, we have formed a Consortium of 5 large private practices in the LA area, which serve patients with HIV/AIDS, and which will refer patients to the central USC site for AMC protocol work. Development of new AMC protocols which do not require specific anti-retroviral therapy has already occurred (protocols 008 and 010), while new innovative protocols for KS (ex: AMC 013), developed by Dr. Gill at USC are close to implementation in the AMC, with 33 patients already on a waiting list at USC. The expertise of our labs and experience will be available to the AMC, which will be considered of the highest priority for our Group.
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