PHASE I/II - CLINICAL EVALUATION OF BIOLOGICAL RESPONSE

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Independently and not as an agent of the Federal Government, this Master Agreement (MA) holder shall conduct clinical trials of biological response modifiers (BRMs) in accordance with protocols approved by the National Cancer Institute (NCI), which are submitted in response to individual Master Agreement Orders (MAOs) issued under the MA. Each MAO will entail the performance of at least one such clinical trial. In conducting such protocols, the MA holder shall furnish all services, qualified personnel, materials, equipment, and facilities not otherwise provided by the Government under the terms of the MAO. Depending upon the specific requirements of the MAO, clinical protocols shall entail study of any of a number of BRMs, including monoclonal antibodies and related constructs, cytokines, growth/differentiation factors, tumor vaccines, adoptive transfer of cells, gene transfer, anti-metastatic agents, anti-oncogene agents, or some combination of these. Objectives of each protocol shall include assessment of toxicity of the treatment regimen, exploration of mechanisms of antitumor action, observation of antitumor responses, and measurement of specific laboratory parameters appropriate for that protocol. Protocols shall be formally approved by the NCI, and monitored by the NCI's Clinical Trial Monitoring Service. The MA holder shall comply with all federal regulatory requirements for clinical trials of experimental agents.