We propose the formation of a consortium of Northern California institutions including San Francisco General Hospital, the UCSF Medical Center, the UCSF/Mt. Zion Cancer Center, the Kaiser San Francisco Medical Center and the UC Davis Medical Center for the conduct of clinical trials in patients with HIV-associated malignancies. This group of institutions will function as a participating member of the National Cancer Institute AIDS Malignancies Clinical Trials Consortium. The five institutions will work together as one unit with a full time data manager for the San Francisco group who will be dedicated to the consortium and will travel to each of the participating sites as necessary for the monitoring of patients on consortium clinical trials. The UC Davis Group will have a second, part-time data manager. The clinicians will interact closely with the San Francisco General Hospital AIDS Immunobiology Lab under the direction of Dr. Michael McGrath who will perform necessary laboratory studies on lymphoma specimens including flow cytometry, immunophenotyping, immunoglobulin gene rearrangement studies, and cytokine studies. As San Francisco General is one of three national NCI- supported AIDS Malignancies Tissue Repositories, there will be close interaction through the repository's principal investigator Dr. Michael McGrath. In addition, the San Francisco General Hospital General Clinical Research Center (GCRC), which has been actively involved in a variety of clinical trials in HIV disease, will be available for both inpatient and outpatient drug administration and collecting of pharmacokinetic specimens if required. Clinical trials proposed for consortium studies include hormonal manipulations, radioimmunoconjugate therapy and chemotherapy plus toremifene for Kaposi's sarcoma. For non-Hodgkin's lymphoma we propose a pilot study of administering CD8 tumor infiltrating T cells after expansion with IL2 following completion of a feasibility trial now ongoing, a clinical trial of interleukin 4 administration, to interfere with tumor promoting IL-6, and radioimmunoconjugate therapy.
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