The University of Chicago Phase II Consortium (UC P2C) is composed of 11 academic sites and community-based institutions. The Consortium conducts phase II and early clinical trials of NCI-sponsored agents. The studies evaluate biologic effects of these agents on their molecular targets, other relevant biologic effects, and determine clinically relevant outcomes/correlates. Organ specific phase I studies, phase II studies, and pilot protocols that explore promising combination therapies including the addition of radiotherapy to cytotoxic and molecularly targeted agents comprise the scope of work. The NCI-IND agents to be studied include agents developed by the pharmaceutical industry and provided to the NCI for collaborative development; agents developed by academic investigators and/or the Developmental Therapeutics Program (DTP), DCTD, NCI; agents which have completed some or all Phase I testing, and; combinations of agents for which the individual toxicities are known. The major emphasis is on rapid initiation, completion, and data reporting. NCI staff notify the Principal Investigator or his team of high priority studies. The NCI also considers investigator-initiated trials for credit under this contract based on available resources and priorities.
Specifically, the University of Chicago Phase II Consortium:
- Rapidly conducts clinical trials necessary to assess the anti-tumor activity and carries out the development plans for NCI-sponsored agents of varying classes, many of which are directed at new cancer targets. While the majority of trials are phase II, some studies designed to develop or assess dose, schedule and pharmacodynamic questions are conducted under this contract.
- Obtains and processes blood, normal and tumor tissue from patients and carries out imaging evaluations for research purposes when required by the protocols
- Studies relevant biologics effects of new agents
- Studies relevant pharmacology
- Determines the antitumor activity of selected combinations of antitumor agents or combinations involving radiotherapy; and
- Determines the safety and efficacy of these agents and explore pharmacokinetic/ pharmacodynamic correlations in special patient populations, such as those with impaired end-organ function, geriatric populations, under-represented racial and/or ethnic groups in whom differences would be anticipated.