From OHC

December 16, 2019

When an OHC cancer patient meets with their doctor and care team, they are always informed of any clinical trial that may help their condition. The benefit of this standard of care at OHC is twofold: the patient may gain early access to the most promising treatment for their cancer, and they are helping researchers obtain the information that is necessary for approval by the Food and Drug Administration (FDA) which, in turn, makes the treatment available to all patients worldwide.

“In order for researchers to make new cancer treatments available to everyone, we are highly dependent upon patients being willing to participate in clinical trials,” explained David M. Waterhouse, MD, MPH, medical oncologist, hematologist and co-director of research at OHC. “Without their participation, it would be difficult to make future breakthrough treatments available to all patients all over the world and improve their outcomes.”

In 2019, OHC doctors offered 55 clinical trials and, thanks to their patients who enrolled in the trials, many have demonstrated promising results. Here is a sample of some of the noteworthy clinical trials – and their promising new treatments – that OHC brought to patients in the region in 2019.

Chimeric Antigen Receptor T-cell Therapy (CAR-T)
A new approach to the treatment of blood cancers shook the cancer world with the FDA approval of chimeric antigen receptor T-cell therapy (CAR-T), and in 2018, OHC was the first and is the only adult cancer group in the region to offer CAR-T to adults with blood cancers. In 2019, OHC opened three clinical trials evaluating an expansion of the use of CAR-T therapy.

One trial is evaluating JCAR017, a new CAR-T therapy, that has demonstrated fewer sides effects and may be ideal for cancer patients with other complex conditions that make them ineligible for a stem cell transplant or the current CAR-T therapy. A second clinical trial is also evaluating JCAR017, but for patients whose B-cell non-Hodgkin’s lymphoma hasn’t responded to chemotherapy or has returned after chemotherapy. The goal of these trials is for CAR-T to be a viable option for more cancer patients.

“CAR-T has already been FDA-approved for the treatment of some blood cancers, and almost half of OHC patients treated with CAR-T have experienced a remission. If these clinical trials show promising results, it would allow for even more patients to be treated with CAR-T therapy,” said OHC’s James H. Essell, MD, medical oncologist, hematologist, and blood and marrow transplant specialist. Dr. Essell is a national expert and author who is also leading the CAR-T program for The US Oncology Network as Chair, Cellular Therapies.

OHC has a third upcoming CAR-T clinical trial that will evaluate tisagenlecleucel (Kymriah) as another option for patients whose B-cell Non-Hodgkin lymphoma cancer hasn’t responded to standard treatment.

OHC patient Bill Willoughby received CAR-T therapy in July for his non-Hodgkin’s lymphoma. Later, when asked about his treatment, Bill said, “I had my last scan a few weeks ago and they said the cancer in my lungs is gone, the cancer in my liver has decreased, and the spots in my bones have decreased. I thought I had run out of options, but OHC was my light at the end of a tunnel.”

Learn more about these trials here, trials #17006 and #17007.

Lung
OHC’s David M. Waterhouse, MD, MPH, is leading a clinical trial as the national principal investigator to evaluate a new treatment option for patients whose advanced non-small cell lung cancer has not responded to chemotherapy or immunotherapy treatments. The treatment is a combination of the drug, Sitravatinib, which binds to an enzyme and works to destroy cancer, with Nivolumab, an immunotherapy drug that helps your immune system cells attack cancer cells. This combination is being tested against the use of the chemotherapy drug, Docetaxel.

“This is like a two-pronged assault. On one hand, we have a drug that will attack the cancer directly. On the other hand, we have a drug that helps your immune system attack the cancer,” explained Dr. Waterhouse. “We’ve had success with this approach with other cancers, and now we may have similar results with lung cancer. We want to be able to tell these patients there’s still hope for their condition.” Learn more here, trial #MRTX-500.

Another OHC clinical trial is for patients with early stage non-small cell lung cancer to evaluate the use of the immunotherapy drug, durvalumab, administered after a patient has received stereotactic body radiation therapy (SBRT) and chemotherapy. The trial will help determine if durvalumab improves the overall survival rate for patients whose cancer is inoperable or doesn’t respond to standard treatment.

“The use of immunotherapy has demonstrated promising results in patients with operable non-small cell lung cancer,” said OHC’s Joseph Shaughnessy, MD, radiation oncologist, who is the principal investigator for this clinical trial. “Now we will see if it is effective with inoperable cancer that doesn’t respond to standard treatment.” Learn more about this clinical trial here.

Ovarian
“Women with advanced stage ovarian cancer need more treatment options,” said Cynthia Chua, MD, OHC medical oncologist and hematologist who is the principal investigator of a clinical trial at OHC evaluating rucaparib (a targeted drug) in combination with nivolumab (an immunotherapy drug) as a maintenance therapy in patients with newly diagnosed advanced ovarian cancer who haven’t had a response to a chemotherapy. Immunotherapy drugs, like nivolumab, have had success in other cancers, but ovarian cancer trials aren’t seeing as high of response rates. So, in this trial, OHC researchers are trying to improve those rates by combing an immunotherapy drug with a targeted therapy drug.

“This clinical trial is important for two reasons: it may lead to a much needed, additional treatment option for women with advanced ovarian cancer and it gives women right here in our region early access to this new treatment, while the rest of the country waits for FDA approval,” Dr. Chua said. Learn more about this trial here.

Breast
Triple-negative breast cancer (TNBC) is the most aggressive form of breast cancer with limited treatment options. That’s why OHC researchers selected to participate in KEYNOTE 522, a clinical trial investigating the use of the immunotherapy drug, pembrolizumab (Keytruda), plus chemotherapy for TNBC.

“I knew the medicine had been proven to help with other cancers, and so far, I feel pretty good. I don’t feel sick and I’m not tired,” said OHC patient Madeline Gillotte, who was diagnosed with TNBC and participated in the trial.

“The data for 18 months shows that in two out of three cases, the cancer was gone after treatment. And there were fewer instances of the cancer returning,” said Patrick J. Ward, MD, PhD, medical oncologist, hematologist, and co-director of research at OHC. “We are now monitoring these patients to see if they remain cancer-free. If they do, this could be life-changing for women with this aggressive cancer.”

Kidney
When Kathy Swensen was diagnosed with advanced renal (kidney) cell cancer in 2017, she felt hopeless. When she was referred to OHC’s Pat Ward, MD, PhD, medical oncologist, hematologist and co-director of OHC’s research program. He recommended Kathy enroll in a kidney cancer clinical trial that was available OHC. He said the drugs being studied had a lot of potential. Before agreeing to the trial, Kathy went to the Cleveland Clinic for a second opinion. She learned that the Cleveland Clinic didn’t offer that specific clinical trial. Then she was adamantly told by the Cleveland Clinic doctor, “If you can get in that trial, do it!” So, Kathy came home to OHC and enrolled.

“That clinical trial gave me hope,” Kathy explained, who has been doing well since starting treatment. “When I received my diagnosis, I thought my life was over, but OHC made me feel like there was still a chance. OHC was like a light that gave me hope.”

“The importance of these clinical trials is they allow OHC to offer patients what they believe could be the next gold standard of care. As data is collected, OHC can help determine if these treatments are ready for FDA approval and widespread use. What researchers are doing at OHC could impact patients across the globe,” Dr. Waterhouse added.

OHC’s nationally-recognized clinical trials program provides patients with early access to promising new treatments. For more information or a list of open clinical trials, visit here. If you’d like a second opinion, please visit ohcare.com or call 1-800-710-4674.

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