Following are public and technical abstracts for the Kidney Cancer Clinical Trials Consortium project funded by the Department of Defense Kidney Cancer Research Program (KCRP) for 2017.
Principal Investigator: Eric Jonasch
Institution: M.D. Anderson Cancer Center, University of Texas
Funding Mechanism: Consortium Development Award
Award Amount: $1,000,000
Public Abstract
Our emerging understanding of how kidney cancer cells interact with normal tissues in the body has led to the development of new treatments capable of directing the body’s immune response against the tumor, as well as treatments that inhibit the growth of blood vessels that feed the tumor. However, the complexity of each patient’s specific tumor environment requires a tailored approach to increase their overall probability of cure. It also requires the use of novel measurement techniques that determine how effective we are at treating the cancer.
This tailored approach is typically not pursued in pharmaceutical company-sponsored clinical trials. For us to develop a new treatment paradigm for patients with advanced or metastatic kidney carcinoma, we need to develop infrastructure that supports clinical studies focused on developing novel strategies, biomarkers, and treatment combinations. These trials will be run at multiple centers of research excellence to permit rapid accrual and to encourage interaction between leaders in the field who are capable of developing the novel tools required to make these trials a success. The Department of Defense Kidney Cancer Research Consortium is set up to create the network required to facilitate implementation of these trials at leading academic centers.
The major goal of this grant is to set up the infrastructure required to efficiently perform cutting-edge, biomarker-driven clinical trials. We will achieve this by developing a harmonized clinical trial approval and monitoring process, by applying a flexible and efficient data management platform, by implementing an innovative sample analysis infrastructure, and by engaging pharmaceutical partners, the patient community, and the companies developing biomarker platforms to participate in the Consortium.
By creating this new infrastructure we will harness the power of leading research institutions around the country, the patient advocacy community, companies developing biomarker platforms, and the pharmaceutical industry to rapidly advance our ability to bring truly personalized treatment to individuals with advanced or metastatic kidney cancer. This two-year grant will set the stage for running these trials in the Consortium. We anticipate that in the next four to five years the Consortium will begin to deliver novel biomarkers and treatment approaches to the kidney cancer community.
Technical Abstract
Background: Current clinical trials are mainly geared toward drug approval as opposed to developing an individualized therapeutic approach for patients with cancer. We now have access to agents capable of modulating specific aspects of the renal cell carcinoma (RCC) tumor microenvironment, but do not have a clinical and translational research infrastructure capable of taking full advantage of these new treatment options. Our ultimate clinical goal is to preselect agents for specific patients based on predictive biomarkers, dynamically monitor response, and anticipate the development of resistance. Creating this new treatment paradigm requires the collaboration of several lead institutions possessing the clinical, translational, and basic science expertise required to perform multi-center, tissue-rich, hypothesis-testing clinical studies and their associated preclinical and correlative analyses.
At this point in time, the multi-center execution of any clinical trial is difficult due to multiple bureaucratic and operational hurdles. These barriers include institution-specific rules for institutional review board (IRB) approval, cumbersome contracting processes, nonstandard standard operating procedures for tissue collection, and the lack of a central coordinating entity. To create infrastructure that will permit efficient execution of informative, translationally focused multi-center clinical trials we have formed the Kidney Cancer Research Consortium, consisting of The University of Texas MD Anderson Cancer Center as the Coordinating Center, UT Southwestern Cancer Center, Cleveland Clinic Foundation Taussig Cancer Center, and Beth Israel Deaconess Medical Center. This consortium includes the two currently funded Specialized Programs of Research Excellence (SPORES) in renal cell carcinoma and world leaders in renal cell carcinoma clinical, translational, and basic research.
Objective: To achieve our goal of creating an efficient, multi-center clinical trials coalition, we will develop a harmonized protocol approval and monitoring process, apply a flexible and efficient data management platform, create an innovative sample analysis infrastructure, and create industry partnerships to support and sustain the consortium. Oversight will occur in the form of a steering committee comprised of physicians from the various consortium members and patient advocates, an external advisory board, and a peer review mechanism for trials and techniques.
Collaboration: The KCRC will be led by Dr. Eric Jonasch, a leader in translational and clinical research. The coordinating center will draw on MD Anderson Cancer Center’s extensive experience in clinical trials management and on the innovative Prometheus clinical and translational research platform. Each Partner site will be an equal partner in the development of the clinical trials infrastructure and in the development of novel trials and biomarkers. The KCRC will build on existing clinical trials and translational research infrastructure developed by each member site to accelerate consortium development and clinical trials execution once the KCRC has matured at the end of or before the two-year inception period. Completing the goals of the KCRC will position us to rapidly launch and complete novel trials that arise from consortium members and from industry partners.