This project encompasses a multi-disciplinary team of basic scientists and clinical investigators dedicated to finding effective new therapies for patients with cancer. The Ohio State University Comprehensive Cancer Center (OSUCCC) is a comprehensive biomedical research campus with strong collaborations between experienced investigators from multiple oncologic disciplines and a vibrant pattern of discovery in the basic sciences. For the purposes of this proposal, the OSUCCC will partner with investigators at the University of Kentucky Markey Cancer Center (MCC) and the University of Utah Huntsman Cancer Institute (HCI) with whom they have had a strong relationships in the past. These sites provide access to a large population of cancer patients that requires access to cancer clinical trials, many of whom reside in rural areas such as Appalachia or the American West. Under the leadership of Dr. William Carson, a surgeon with experience in immune therapy, and Translational Scientist Dr. Jennifer Woyach, a hematologic oncologist with skill in developing targeted therapies, this highly integrated team will explore novel therapeutic agents and treatment modalities, test new immune-based therapies, evaluate drug resistance mechanisms and explore the promise of genomic profiling of the cancer cell in order to develop more effective treatments for cancer. Notably, investigators in this experimental therapeutics program have been engaged in the conduct of phase I/II cancer studies for decades and are experienced in the design and conduct of correlative laboratory studies that can confirm the ability of a new drug to hit a specific molecular target and define a precise mechanism of action. Ohio State has collaborated extensively with other cancers centers dedicated to experimental therapeutics and will continue to do so within the context of the UM1 mechanism. The existence of strong laboratory bench research and pharmacology at each site will ensure that this group of translational investigators will continue to generate new concepts for submission within the NCI?s Experimental Therapeutics Clinical Trials Network (ETCTN) mechanism. A major goal of this consortium is to accrue over 100 patients per year to ETCTN studies and in the last grant year 102 enrollments were recorded in a variety of cancer types. Of prime importance to this consortium is the education and training of early career investigators so that they are prepared to lead new translational studies. Indeed, each of the last six studies from this clinical research group has had an early career investigator as its leader. The experience, diversity and cohesiveness of this research team combined with an unwavering commitment to ETCTN goals and principles will position it for continued success and innovation within this exciting clinical research mechanism.
The Early Therapeutics Clinical Network (ETCTN) at The Ohio State University (OSU) will identify new agents with promising laboratory studies and develop them into new drugs for the treatment of patients with advanced cancer who have exhausted their treatment options. Physicians, nurses and research coordinators will carefully monitor patients receiving these drugs to make sure that they are safe. Patients will also undergo sampling of their blood and have their tumors biopsied. These tissues will be analyzed by modern methods to determine the levels of the new drug in the bloodstream and test whether they are having the predicted effect on the cancer cells. The aim of the clinical study may be to simply determine if the drug can be given safely (phase I) and in other instances the goal of the study will be to see whether the new drug or drug combination can shrink the tumor and enable the patient to live longer. The consortium will consist of OSU, the University of Kentucky and the University of Utah in order to bring the evaluation of novel agents to three states with a high burden of cancer.
