Stephenson Cancer Center Joins Additional Clinical Trials Networks

Stephenson Cancer Center at OU Medicine has been selected to join additional networks within the National Cancer Institute that will expand clinical trials in two areas – early-phase drugs to treat cancer and therapies to prevent cancer.

Stephenson Cancer Center took part in a highly competitive process to earn membership in the networks – the Experimental Therapeutics Clinical Trials Network (ETCTN) and the Cancer Prevention Clinical Trials Network (CP-CTNet). Both will increase the number and types of clinical trials available in Oklahoma for a wide variety of cancers.

“Being selected to join these two networks will allow Stephenson Cancer Center to broaden the availability of clinical trials to people across Oklahoma,” said Robert Mannel, M.D., director of Stephenson. “These two networks provide unique trials offered nowhere else in Oklahoma or the region – one focusing on promising new drugs, and the other on therapies designed to prevent cancer. This is an exciting step in our continued growth as a National Cancer Institute-Designated Cancer Center.”

Participation in the Experimental Therapeutics Clinical Trials Network is highly collaborative -- Stephenson Cancer Center will conduct clinical trials with other NCI-Designated Cancer Centers like Yale Cancer Center, Vanderbilt-Ingram Cancer Center, Moores Cancer Center at UC San Diego Health, Siteman Cancer Center at Washington University in St. Louis, and Herbert Irving Comprehensive Cancer Center at Columbia University.

Trials will focus on both solid tumors and blood cancers, including rare cancers or areas with the most unmet needs. Some drugs have never been tested in humans before, and other trials will test drugs in combination with other therapies, such as radiation, said Associate Director for Clinical Research Kathleen Moore, M.D., who will lead ETCTN at Stephenson. The “TSET Phase I Program” will provide the infrastructure for conducting many of these trials.

The ETCTN also supports junior faculty members with mentorship as they develop protocols for their own clinical trials. One Stephenson Cancer Center trial that has already been approved is being developed by gynecologic oncologist Camille Gunderson, M.D., who is testing a two-drug combination for recurrent ovarian cancer. Gunderson’s trial is unique because she is part of team that developed a biomarker panel common to several types of cancer, including pediatric and adult brain cancers and melanoma.

“All of these cancers have common biomarkers, so we can learn a lot about multiple disease types while testing this drug combination,” Moore said. “It is an innovative trial and is one of many opportunities our patients will have to access early-phase drugs or drug combinations.”

Gunderson said she worked for several months to develop the trial with experts in pharmacokinetics, cancer biology, biomarkers, clinical trial execution and cancer therapeutics.

“The goal of the trial is to determine the safety and efficacy of the drug combination in women who have already received one of our best drugs for ovarian cancer, called PARP inhibitors,” Gunderson said. “Patients will receive the PARP inhibitor along with an FDA-approved breast cancer drug, due to strong rationale supporting activity in ovarian cancer. I am excited to be able to offer patients a great option in a disease state that is difficult to treat.”

The Cancer Prevention Clinical Trials Network takes a different approach – preventing cancer before it ever has a chance to start. Therapies designed to prevent cancer must go through the same clinical trial process as treatments and be proven safe and effective before moving into larger clinical trials. People enrolled on these trials may be at high genetic risk for developing cancer, or they may be people with no known risk. The goal is to understand if a therapy reaches its intended target and if it functions as anticipated.

“We know, for example, that if a patient has a colonoscopy that shows a precancerous polyp, that polyp needs to be removed, but the patient is also at increased risk for developing colon cancer,” Mannel said. “So how do we prevent that from occurring? To do that, we need to understand the pathways and the proteins that are allowing the cells to become malignant. Then we want to test a method of preventing the cells from starting on that pathway toward cancer.”

As a member of CP-CTNet, Stephenson is again part of a consortium of institutions conducting clinical trials, which is important not only for larger trial enrollment, but to represent people from all areas, cultures and ethnicities in the United States.

“We are a rural state, and we have a unique ethnic diversity that needs to be reflected in prevention studies that are defining new strategies for prevention of cancer, or prevention of toxicities with cancer treatment,” Moore said. “Instead of focusing trials in one or two big cities, this consortium represents a wide swath of the U.S. demographic.”