CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS

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The Contractor will conduct clinical trials of biological response modifiers in cancer patients. Working with the Project Officer, the Contractor will identify two or more clinical trials to be conducted per contract year. Agents to be studied will be supplied by the government or otherwise approved by the Project Officer. All clinical protocols will be submitted to the Project Officer for NCI approval. The overall goal of the contract will be to address fundamental issues in the use of monoclonal antibodies and targeting agents in the treatment of patients with cancer. Each clinical trial will be developed, conducted, and analyzed as part of a specific Task Order. At a minimum, each protocol will assess the toxicity of the treatment regimen, explore mechanisms of antitumor effect and resistance, observe clinical antitumor responses, and monitor specific immunologic parameters appropriate to that clinical trial and approved by the Project Officer. At the conclusion of each clinical trial, the Contractor will summarize results in a written Report of Clinical Trial submitted to the Project Officer.