OSUCCC – James Clinical Research Update

Groundbreaking cancer research at the OSUCCC – James translates into innovative clinical care that precisely targets the unique biologic causes of each patient’s individual cancer.

Research is more often in the public spotlight, but clinical care is equally important. Here, we offer highlights of clinical research accomplishments within Ohio State’s cancer program:

The OSUCCC – James has been awarded and holds three separate grant contracts with the National Cancer Institute (NCI) totaling millions of dollars for NCI-related collaborative work designed to improve clinical care and patient outcomes across the country. These include:

  • A grant establishing Ohio State as an NCI National Clinical Trials Network (NCTN) Lead Academic Participating Site. Richard Goldberg, MD, physician-in-chief at the OSUCCC – James, is principal investigator (PI). The NCTN develops and conducts state-of-the-art cancer treatment and advanced imaging clinical trials, especially large multi-institutional trials evaluating new cancer therapies and related clinical approaches for adult and pediatric patients. The grant supports OSUCCC – James participation in the NCI-funded clinical oncology cooperative groups.
  • A grant for conducting phase I clinical trials on novel anticancer agents (new drugs and drug combinations) as part of an NCI Experimental Therapeutics-Clinical Trials Network (ET-CTN) that supports the NCTN. Michael Grever, MD, professor and chair of the Department of Internal Medicine at Ohio State and co-leader of the Leukemia Research Program at the OSUCCC – James, is PI for the grant. The OSUCCC – James works with other network members to define the drug development plan and conduct clinical trials for these novel anticancer agents.
  • A grant for conducting phase II clinical trials to test novel anticancer agents in new indications. Miguel Villalona, MD, professor and director of the Division of Medical Oncology at Ohio State and a member of the Translational Therapeutics Program at the OSUCCC – James, is PI for the grant, which enables the OSUCCC – James to conduct phase II studies as the lead institution in a consortium that includes three other cancer centers as collaborators.

On Feb. 12, 2014, the U.S. Food and Drug Administration expanded the approved use of the drug ibrutinib to certain patients with chronic lymphocytic leukemia (CLL). Much of the clinical and basic-science research that led to this approval was conducted at the OSUCCC – James.

Ibrutinib is the first drug designed to target a protein essential for CLL-cell survival and proliferation. CLL, the most common form of chronic leukemia, is currently incurable.

The Ohio State work was co-led by John C. Byrd, MD, who directs the Division of Hematology at Ohio State and co-leads the Leukemia Research Program at the OSUCCC – James, and by Amy Johnson, PhD. Other contributing team members include: Jennifer Woyach, MD; Amy Stark, MAS; Susan Geyer, PhD; Jeffrey Jones, MD, MPH; Joseph Flynn, DO, MPH; Kami Maddocks, MD; Leslie Andritsos, MD; Samantha Jaglowski, MD, MPH; and Kristie Blum, MD.

Byrd says his team’s clinical studies consistently suggested that ibrutinib is a highly active oral therapeutic that produces a high rate of lasting remissions with acceptable side effects in CLL patients who have relapsed or whose cancer has resisted standard treatment. “Patient responses can last for many months,” he adds, “in part because patients are willing to remain on the drug since side effects are tolerable.”

Also, in November 2013 the FDA granted accelerated approval for using ibrutinib to treat certain patients with mantle cell lymphoma. This approval was based on results from a multi-institutional clinical study co-led by Kristie Blum, MD, of the OSUCCC – James.

In 2013, the NCI awarded a prestigious five-year, $11.3 million Specialized Program of Research Excellence (SPORE) grant to help a team of researchers and clinicians at the OSUCCC – James improve the lives of patients with thyroid disease. The PI is Matthew Ringel, MD, who directs the Division of Diabetes, Endocrinology and Metabolism at Ohio State and co-leads both the Thyroid Cancer Unit and the Molecular Biology and Cancer Genetics Program at the OSUCCC – James.

The SPORE grant, which also involves researchers at The University of Texas MD Anderson Cancer Center, supports four interactive projects that seek to identify genetically at-risk individuals and thus allow for early diagnosis and prediction of tumor behavior, development of approaches to minimize side effects of treatments, and development of better biomarkers and treatment options for metastatic disease.

The OSUCCC – James is partnering with Moffitt Cancer Center in Tampa, Fla., to form what is likely the largest collaboration of its kind to accelerate cancer research discoveries that can translate to more effective clinical care.

The Oncology Research Information Exchange Network (ORIEN) will hasten the development and delivery of more precise cancer treatments, diagnostic tools and prevention strategies through secure research sharing among the nation’s top cancer centers and institutions.

The partnership will launch with more than 100,000 consented patients who have agreed to donate their tissue and clinical data for research that will help scientists better understand cancer at the molecular level.

ORIEN will use a single protocol, called Total Cancer Care®, to create a collaborative “rapid learning” environment that will share de-identified patient data to hasten the development of targeted treatments and more quickly match eligible patients to clinical trials.

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