The theme of this program project is to translate innovative ideas derived from the laboratory or clinic to clinical multimodal trials. These projects are designed to integrate two or more modalities such as chemotherapy, immune response modifiers, hyperthermia, and radiation therapy into small pilot studies. The approaches are based on the laboratory or clinical studies of the investigators and, if successful, can be expanded to national Phase III trials through ECOG and other groups. The projects are inter-related by integrating results from one trial to another in the second and third years. The laboratory components will measure specific parameters that relate the clinical outcome to the laboratory concepts being tested. Each of the investigators has other research support that will be used to expand the scope of the projects. Overall Objective . To improve cancer treatment of selected solid tumors by translating conceptual hypotheses through well-designed, innovative multimodal clinical trials.
Specific Aims . To increase the chances of curing metastatic breast cancers through high-dose-density chemotherapy and hormonal blockade. . To combine a monoclonal antibody and IL-2 in vivo to activate antibody- dependent cytotoxic immune responses. . To enhance the effects of chemotherapy with hyperthermia and the biochemical modulator, thymidine. . To study the potential augmentation of radiation sensitivity with interferon. . To develop statistical methodology for small-scale multimodal trials which both maximize the confidence of answers and conserve patients.
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