MedStar Health News

When Two Areas of Science Aimed at Beating Cancer Come Together

(Washington, D.C.,) – A Maryland woman is benefiting from the intersection of two promising fields of science: precision medicine to genetically profile cancer and immunotherapy to unleash the immune system to fight it.

It’s a case her doctors are calling “remarkable.”

Diane Lucey, 49 of Leonardtown, Maryland was living in Georgia in 2014 when she noticed a small bump in her mouth.  The two centimeter tumor was determined to be a rare type of cancer called neuroendocrine carcinoma. She had it surgically removed, received six weeks of radiation and thought she was cancer free. But in the summer of 2016 a scan revealed cancer in her liver and her right lung.  

“It came from out of the blue,” Lucey says.  “I thought I was done with my cancer when it came back.”

By then Lucey was working as a chemist for Calvert County and living in Leonardtown, Maryland. Her oncologist at nearby MedStar St. Mary’s Hospital sent her to MedStar Georgetown where she would have full access to the latest treatments as well as clinical trials through the Georgetown Lombardi Comprehensive Cancer Center.

“This was a rare disease in a young, healthy person,” says Amir Khan, MD, medical director of Cancer Care and Infusion Services at MedStar St. Mary’s and Lucey’s oncologist.  “I wanted to have her treatment plan formalized quickly and to see if there were other options for her beyond standard therapy, which is chemo therapy.”

Lucey next met with Louis M. Weiner, MD, director of MedStar Georgetown University Hospital’s Lombardi Comprehensive Cancer Center and Georgetown Lombardi, the research arm of MedStar Georgetown. “Here at Georgetown, we partner with Caris Life Sciences to perform detailed molecular profiling of patients’ tumors. In Ms. Lucey’s case we sent part of her liver tumor to Caris and found the cancer cells had the right target, PD-L1 expression, that clinical trials have shown make cancers sensitive to certain immunotherapy drugs.”

In October 2016 Lucey began receiving injections of the immunotherapy nivolumab, sold under the brand name Opdivo, one hour every two weeks for 12 weeks. Because Georgetown Lombardi is part of the MedStar system, Lucey was able to receive her treatments closer to home at MedStar St. Mary’s Hospital.

Her first scan in January 2017 showed her liver tumor had shrunk by half and the lesions in her lung were shrinking as well.

“My doctors were thrilled and of course I’m thrilled at the results,” says Lucey. “And the best part is that I’ve been able to work and live my daily normal life with no pain or fatigue, no hair loss, no nausea or loss of appetite. Compared to the radiation I had before, this immunotherapy was nothing.”

Born and raised on the Florida coast, Lucey is an avid boater, loves to fish and spend time on the nearby Chesapeake Bay. “I’m at the beach and on the water as much as I possibly can,” says Lucey. “With this treatment I’ve been able to continue to make plans to enjoy the things I’m passionate about including a big fishing trip to Florida with my family this year. I’m also pursuing my other hobbies like golf, restoring old furniture, painting and making jewelry.”

“Ms. Lucey’s case is a perfect example of what those of us who worked on former Vice President Joseph Biden’s Cancer Moonshot believe is the future of beating cancer,” says Dr. Weiner who served on the National Cancer Institute’s blue ribbon panel working group on immunotherapy as part of the National Cancer Moonshot Initiative.

“Of the 13 critical areas we recognized, this case satisfies three: delivering cutting edge cancer care to patients where they live, capturing the benefits of precision medicine to treat the right cancer with the right medication at the right time, and to harness the immune system to control and attack the cancer.”

Nivolumab is FDA approved for advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma or bladder cancer.

“The only side effect I had was a small rash on my belly, but that went away with a course of Prednisone,” says Lucey.

Side effects, sometimes serious ones, occur in fewer than 10 percent of patients taking immunotherapy. Immunotherapy does not work in all patients.

“Ms. Lucey’s situation is also a great example of how MedStar Georgetown Cancer Institute, a network of hospitals linked with clinical and research priorities, uses the resources available at our NCI-designated Comprehensive Center to work collaboratively to provide patients in somewhat distant areas access to the latest advances in world class cancer care. She received tomorrow’s treatments today, without leaving her hometown,” says Dr. Weiner.

“Ms. Lucey is very lucky,” says Dr. Khan.  “Immunotherapy is another tool in the hands of physicians and it will impact some patients more than others. We don’t know how long it will work for her but more and more people are living better and longer with cancer these days.  I wish all my patients could benefit this way.”

Dr. Weiner says research shows that when immunotherapy works rapidly, as in Lucey’s case, the results tend to be more long lasting.

“My daily life is normal.  I don’t think about having cancer.  I just keep living my life being very grateful and hoping for continued good news,” says Lucey.

WASHINGTON  – Georgetown University Medical Center (GUMC) today announces the launch of a phase II clinical trial to study the safety of the cancer drug nilotinib and its effects on clinical outcomes and biomarkers in people with Parkinson’s disease.  

GUMC is recruiting volunteers for the study in collaboration with its clinical partner, MedStar Georgetown University Hospital. 

The clinical trial is a phase II, randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of low doses of nilotinib, the efficacy on disease biomarkers, and clinical outcomes in people with mid-stage Parkinson’s disease. Fernando Pagan, MD, medical director of the GUMC Translational Neurotherapeutics Program and director of the Movement Disorders Clinic at MedStar Georgetown University Hospital will serve as principal investigator on this study.

As part of the year-long random ascending dose trial, a third of the participants will receive 150mg of nilotinib, another third will receive 300mg of nilotinib and the final third will receive a placebo (inactive drug). Clinical outcomes will be assessed at six and 12 months and compared to assessments at the start of the trial. A one-year open-label extension trial, in which all participants will be randomized to 150mg or 300mg nilotinib, is also planned upon completion of the placebo-controlled trial to evaluate nilotinib’s long-term effects.

The clinical trial follows a proof of concept study conducted at Georgetown (published July 11, 2016 in the Journal of Parkinson’s Disease) providing molecular evidence that nilotinib significantly increased brain dopamine (the chemical lost as a result of neuronal destruction) and reduced toxic proteins linked to disease progression in Parkinson’s disease or dementia with Lewy bodies. Twelve participants were enrolled in the initial study; one patient withdrew due to an adverse event. Researchers say the drug appeared to be safe and well tolerated in the remaining 11 participants who completed the study.

“The early proof of concept study conducted in 2015 and published in 2016 provided encouraging results, but we won’t know the exact effects of nilotinib on Parkinson’s disease until larger trials like this new one are complete,” says Pagan.

“I am pleased to offer this study to my patients, which demonstrates the importance of teaming Parkinson’s care with academic research. Only through clinical trials will we be able to move the field forward so that we can offer better treatments to our patients in the future,” he adds.

Nilotinib is approved by the U.S. Food and Drug Administration at much higher doses for the treatment of chronic myeloid leukemia (CML). In 2016, the U.S. Food and Drug Administration reviewed Georgetown’s investigational new drug application (IND) for the nilotinib study in Parkinson’s disease and informed GUMC investigators that the trial could proceed.

The Parkinson’s study and the recently announced Alzheimer’s clinical trial with nilotinib build on research from the GUMC Translational Neurotherapeutics Program led by Charbel Moussa, MB, PhD. He and his colleagues are examining tyrosine kinase inhibitors, like nilotinib, in the treatment of neurodegenerative diseases. Tyrosine kinases appear to play a role in neurodegeneration, protein clearance and inflammation. (Moussa is an inventor on a US patent owned by Georgetown University and on other pending US and foreign patent applications for use of nilotinib and other tyrosine kinase inhibitors for the treatment of neurodegenerative diseases).

The Parkinson’s study is funded by the generous support of donors. Novartis, the maker of nilotinib, is providing nilotinib and matching placebo free of cost to Georgetown University for all participants while on the study.

More information can be found at ClinicalTrials.gov. Patients and families can sign up here to receive more information about the Parkinson’s study and other Georgetown neurodegenerative clinical trials.

Precision Medicine and Immunotherapy: Tomorrow’s Cancer Treatments Today at MedStar Georgetown

(Washington, D.C.,)  – A Maryland woman is benefitting from the intersection of two promising fields of science: precision medicine to genetically profile cancer and immunotherapy to unleash the immune system to fight it.

It’s a case her doctors are calling “remarkable.”

Diane Lucey, 49 of Leonardtown, Maryland was living in Georgia in 2014 when she noticed a small bump in her mouth.  The two centimeter tumor was determined to be a rare type of cancer called neuroendocrine carcinoma. She had it surgically removed, received six weeks of radiation and thought she was cancer free. But in the summer of 2016 a scan revealed cancer in her liver and her right lung.  

“It came from out of the blue,” Lucey says.  “I thought I was done with my cancer when it came back.”

By then Lucey was working as a chemist for Calvert County and living in Leonardtown, Maryland. Her oncologist at nearby MedStar St. Mary’s Hospital sent her to MedStar Georgetown where she would have full access to the latest treatments as well as clinical trials through the Georgetown Lombardi Comprehensive Cancer Center.

“This was a rare disease in a young, healthy person,” says Amir Khan, MD, medical director of Cancer Care and Infusion Services at MedStar St. Mary’s and Lucey’s oncologist.  “I wanted to have her treatment plan formalized quickly and to see if there were other options for her beyond standard therapy, which is chemo therapy.”

Lucey next met with Louis M. Weiner, MD, director of MedStar Georgetown University Hospital’s Lombardi Comprehensive Cancer Center and Georgetown Lombardi, the research arm of MedStar Georgetown. “Here at Georgetown, we partner with Caris Life Sciences to perform detailed molecular profiling of patients’ tumors. In Ms. Lucey’s case we sent part of her liver tumor to Caris and found the cancer cells had the right target, PD-L1 expression, that clinical trials have shown make cancers sensitive to certain immunotherapy drugs.”

In October 2016 Lucey began receiving injections of the immunotherapy nivolumab, sold under the brand name Opdivo, one hour every two weeks for 12 weeks. Because Georgetown Lombardi is part of the Medstar system, Lucey was able to receive her treatments closer to home at MedStar St. Mary’s Hospital.

Her first scan in January 2017 showed her liver tumor had shrunk by half and the lesions in her lung were shrinking as well.

“My doctors were thrilled and of course I’m thrilled at the results,” says Lucey. “And the best part is that I’ve been able to work and live my daily normal life with no pain or fatigue, no hair loss, no nausea or loss of appetite. Compared to the radiation I had before, this immunotherapy was nothing.”

Born and raised on the Florida coast, Lucey is an avid boater, loves to fish and spend time on the nearby Chesapeake Bay. “I’m at the beach and on the water as much as I possibly can,” says Lucey. “With this treatment I’ve been able to continue to make plans to enjoy the things I’m passionate about including a big fishing trip to Florida with my family this year. I’m also pursuing my other hobbies like golf, restoring old furniture, painting and making jewelry.”

“Ms. Lucey’s case is a perfect example of what those of us who worked on former Vice President Joseph Biden’s Cancer Moonshot believe is the future of beating cancer,” says Dr. Weiner who served on the National Cancer Institute’s blue ribbon panel working group on immunotherapy as part of the National Cancer Moonshot Initiative.

“Of the 13 critical areas we recognized, this case satisfies three: delivering cutting edge cancer care to patients where they live, capturing the benefits of precision medicine to treat the right cancer with the right medication at the right time, and to harness the immune system to control and attack the cancer.”

Nivolumab is FDA approved for advanced melanoma, advanced non-small cell lung cancer, advanced renal cell carcinoma, classical Hodgkin lymphoma, advanced squamous cell carcinoma of the head and neck, and urothelial carcinoma or bladder cancer.

“The only side effect I had was a small rash on my belly, but that went away with a course of Prednisone,” says Lucey.

Side effects, sometimes serious ones, occur in fewer than 10 percent of patients taking immunotherapy. Immunotherapy does not work in all patients.

“Ms. Lucey’s situation is also a great example of how MedStar Georgetown Cancer Institute, a network of hospitals linked with clinical and research priorities uses the resources available at our NCI-designated Comprehensive Center to work collaboratively to provide patients in somewhat distant areas access to the latest advances in world class cancer care. She received tomorrow’s treatments today, without leaving her hometown,” says Dr. Weiner.

“Ms. Lucey is very lucky,” says Dr. Khan.  “Immunotherapy is another tool in the hands of physicians and it will impact some patients more than others. We don’t know how long it will work for her but more and more people are living better and longer with cancer these days.  I wish all my patients could benefit this way.”

Dr. Weiner says research shows that when immunotherapy works rapidly, as in Lucey’s case, the results tend to be more long lasting.

“My daily life is normal.  I don’t think about having cancer.  I just keep living my life being very grateful and hoping for continued good news,” says Lucey.