Under this incrementally funded 5-year award, the contractor will perform a minimum of two Phase I or Phase II clinical trials annually. Each clinical trial will assess the anti-tumor activity and biological mechanism(s) of action of a cytokine or other immunomodulator (alone or in combination with other such agents or standard therapies). The agent(s) of interest will be selected and provided by the NCI for each study. The clinical protocol for each trial will be developed by the contractor in collaboration with staff of the Biological Response Modifiers Program, NCI, and protocols must have NCI and FDA approval before they can be activated. Performance and results of each trial will be closely monitored by NCI professional staff, with tabulation of data by the NCI contract Clinical Trials Monitoring Service.
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