The USC AIDS-Malignancy Clinical Trials Consortium (AM-CTC) application has the following specific aims: (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; (2) To assure accrual of at least 30 patients per year to these trials; (3) To assure adequate accrual of women and minorities to these trials; (4) To share the experience and expertise of our faculty with other Consortium members; (5) To provide tumor tissue and other relevant biologic materials, derived from patients accrued onto trials, to the NCI funded Tissue and Biological Fluids Banks of HIV Associated Malignancies. The USC School of Medicine provides outpatient care to HIV infected individuals in our designated AIDS Clinic (5P21), in which 4000-4500 patients are seen each month. Since 1987, our AIDS Clinical Trials Group (ACTG) has accrued 1,217 patients onto ACTG protocols, of whom 45.7% have been from-minority racial/ethnic background. We have accrued 113 patients onto ACTG protocols related to malignancy; 45% of these have been of minority backgrounds. Our total accrual onto various AIDS-malignancy protocols consisted of 37 in 1990; 53 in 1991; 116 in 1992; 104 in 1993; 114 in 1994, and 49 in the first 4 mos of 1995. The existence of Women's Interagency HIV Study (WIHS) site at USC will allow access to large numbers of HIV infected women as potential participants in future AM-CTC trials; 326 women are now enrolled at USC's WIHS. Our site has been an active participant in other Consortium trials related to HIV-malignancy, including the AIDS Lymphoma Network, in which we provided 43% of all patients accrued to another grantee's trial, after full completion of our own Network proposal. The USC AIDS Malignancy Program has been actively engaged in Phase I and Il trials related to HIV-related cancers, with participation in 45 such studies, resulting in 17 publications to date, and 30 published abstracts. A total of 103 manuscripts have been published in the broad area of AIDS-malignancy. Detailed mechanisms of data management and quality control are in place, to allow adherence to all protocol requirements in our large group (100+/yr) of protocol patients. Detailed mechanisms of tissue procurement are in place, which served to support our successful application as a current grantee of the NCI Tissue Bank of HIV Malignancies, to which we have already transferred materials. Our group has prior experience in the phase I/Il use of monoclonal antibodies, either alone, or conjugated to toxins or radionucleides; various drugs encapsulated in liposomes; cytokines; anti-angiogenesis compounds; hormonal manipulation; and novel classes of chemotherapeutic agents. Our labs are experienced in cell biology, molecular biology and animal studies. These areas of expertise would be made available to the AM-CTC effort, which would be considered of the highest priority for patient accrual by our Group.
