(Washington, D.C.) When Melvin Denwiddie, 73 was diagnosed with prostate cancer in late 2016 his physicians first told him the “watch and wait” strategy would be sufficient. But in 2017 further testing showed that his cancer had become more aggressive and it was time to get treated.
“My prostate cancer was potentially fatal if I didn’t start treatment,” says Denwiddie. “My choices were surgery to remove the prostate, traditional radiation or proton radiation,” says the great-grandfather of three. “I did my research and I wanted proton therapy. I found that proton therapy would be the most accurate; it would follow the shape of my tumor and would penetrate only the tumor and not any of the tissue outside of the tumor. That was very important to me.”
That’s when he found proton therapy at MedStar Georgetown University Hospital and his radiation oncologist, Jonathan Lischalk, MD.
“It’s important to sit down with patients and discuss their treatment options,” says Dr. Lischalk. “For localized prostate cancer, a variety of treatment options exist including surgery and radiation therapy. Even within radiation therapy, many options exist including proton therapy, x-ray-based therapy, and brachytherapy. Helping a patient understand his treatment options, the related side effects, and the clinical outcomes is extremely important.”
The proton therapy system at MedStar Georgetown is the first and only in the Washington, D.C. metropolitan area and is the first in the world to offer proton therapy with HYPERSCAN™ technology. HYPERSCAN produces beams that are sharper than other proton systems and treats patients faster.
Denwiddie received 43 proton treatments over the course of July through September 2018.
“From my standpoint, proton therapy is a very good treatment process. It was not invasive, it wasn’t painful and I experienced very few side effects,” says Denwiddie. “Aside from my bladder becoming overactive, it was a pretty easy treatment from beginning to end. And any side effects I had are getting better.”
With proton therapy complete, Denwiddie continues with hormone treatments for his prostate cancer under the care of his urology team at MedStar Georgetown.
“Proton therapy is proving to be an excellent option for prostate cancer treatment,” say Ryan Hankins, MD, a urologist at MedStar Georgetown University Hospital. “From a urology standpoint, I am able to use a small needle through the skin to place the needed fiducial markers and gel spacer to help improve patient outcomes and make proton therapy more precise. This is done with no incisions on the skin. Dr. Lischalk and I also coordinate patient visits to help make the patient's visit to MedStar Georgetown as seamless as possible.”
Denwiddie is a retired accountant for NASA but continues to prepare tax returns and represent clients before the Internal Revenue Service. “It’s a labor of love I’ve been practicing since 1972. It’s such a pleasure to know that I can continue to help people when they need it in this way.”
With his wife of more than 50 years newly retired and his prostate cancer treated, Denwiddie looks to the future with optimism and excitement.
“I feel confident that this prostate cancer is a thing of the past. The rest of my life, I’m looking forward to enjoying the freedom and flexibility to move around and travel with my wife. That includes visiting family and places I haven’t had the opportunity to see yet. I’m very excited about my future.”
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(Washington, D.C) Elliott Stevens of Maryland has a new kidney and is cured of hepatitis C after a transplant and treatment at the MedStar Georgetown Transplant Institute that includes the use of newly approved anti-viral medications.
Stevens, 60 was diagnosed with end-stage kidney disease in 2015. He needed a transplant as soon as possible. But because of his blood type and a national waiting list of nearly 100,000 patients, he was told his wait could be seven to eight years. In addition to having kidney disease, Stevens contracted hepatitis C after a blood transfusion he received as a child.
“I had to go on dialysis right away. I know it saved my life but dialysis really tore down my body,” recalls Stevens, recently retired after 28 years at FedEx. “I was hooked to a machine for four hours a day, three days a week and afterwards all I could do was crawl back into bed to rest. I missed my wife and two daughters and could no longer travel.”
But in March of 2017 Stevens got a call from MedStar Georgetown. A kidney was available. The catch was that the kidney was from a hepatitis C – positive donor.
“For more than a decade we have been using kidneys from hepatitis C-positive donors for some recipients already infected with the virus,” says MGTI Transplant Nephrologist Alexander Gilbert, M.D. “We can safely give hepatitis C-positive kidneys to patients who already have hepatitis C because in that case there is minimal risk of transmitting the disease since the patient has already been exposed. Once we get the kidney into the recipient, we can then go back and treat the recipient and cure the hepatitis C. The newest advance in this process is better, more effective treatments for hepatitis C.”
And that’s just what happened in the case of Elliott Stevens.
“I have some family members who have high blood pressure and other health problems that mean they couldn’t be a living donor for me,” says Stevens. “I was weighing that seven year waiting list in front of me and being on dialysis and I looked at my wife and daughters and said, ‘yes I want to take a chance on this and spend more time with them,’” says Stevens. “I didn’t want to wait seven years getting to a critical state medically where I might not be able to survive a kidney transplant.”
“This is exciting because in Mr. Stevens’ case we were able to shorten his wait time from seven or eight years, to barely 400 days, and then cure him of his hepatitis C,” says Matthew Cooper, M.D., director of Kidney and Pancreas Transplantation at the MGTI.
Estel Swayne, 60 of Maryland had a similar experience. After living with diabetes since 1997 she found out in 2015 that she had contracted hepatitis C.
“While I was waiting for a kidney transplant, I was on dialysis,” recalls Swayne. “I was so absolutely exhausted all the time. I just went to dialysis and all I wanted was my bed.”
“We know that dialysis is not a comfortable or easy way to live. Studies show that patients live significantly longer with a kidney transplant versus dialysis,” says Dr. Cooper.
After a few months on the list for a kidney at MedStar Georgetown, Swayne received a kidney from a deceased donor who was hepatitis C-positive.
“I already had hepatitis C, so it wasn’t going to make a difference to me,” says Swayne. “It’s not like they could give me something I didn’t already have. I knew I couldn’t stay on dialysis too long or other things should start happening to me and I might not be a transplant candidate.”
“What’s made this possible is the advent of new anti-viral medications approved in 2015 that we expect to permanently cure a patient of their hepatitis C more than 95% of the time, with few side effects and only a short course of treatment, about 12 weeks,” says Dr. Gilbert. “The old hepatitis C medications only worked 60% of the time, came with serious side effects and had to be taken for six months or longer.”
“The last time I came for my checkup, there was no sign of hepatitis in my body,” says Stevens. “I consider this a win-win. I no longer have kidney disease and I am cured of hepatitis C. I am so grateful and I feel wonderful. I am back to taking walks with my wife, spending more time with my daughters and I’m back to volunteering in my church. I could not be happier.”
After her transplant in September 2016 and a course of the new hepatitis C medication, Swayne’s blood work confirmed that she is free of the hepatitis C virus.
“I feel great. I actually have the energy to do things,” says Swayne. “I like to fish and hike and spend hours and hours in my garden. I hadn’t been able to do these things in quite some time. I go all over the place now.”
“Our next step is to transplant hepatitis C-infected kidneys into carefully selected patients who need a kidney but do not have hepatitis C and then treat them for hepatitis C after transplant,” says Matthew Cooper, MD, “Our goal is to get them off the long waiting list and return them to their lives.”
The MGTI plans to increase the availability of kidneys from hepatitis C-positive donors through future studies.
A recent study of 20 patients without hepatitis C, who received hepatitis C-positive kidneys, found that all were free of the disease after transplant and treatment.
“This could be a game changer,” says Dr. Gilbert. “This wouldn’t be for everyone but could be ideal for patients who don’t do well on dialysis and who face longer wait times. Their only choice for a new kidney might be to receive a kidney from a hepatitis C-positive donor, then get treatment for hepatitis C after transplant.”
“I hope I can encourage others with my successful outcome along the way,” says Stevens. “I just feel so grateful to my donor and to my Georgetown transplant team, that I hope I can give back what someone has given me, which is a second chance at life.”
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(Washington, D.C) April 17, 2018- For the first time, cancer patients in the Washington, D.C. metropolitan region have access to the latest cancer-fighting technology, proton radiation therapy, now available at the MedStar Georgetown University Hospital Proton Therapy Center.
Martha Ramos, 53 of Maryland became MedStar Georgetown’s first patient to receive proton therapy. Ramos is being treated for recurrence of a brain tumor.
“It’s encouraging to know that this kind of radiation will result in less damage to the healthy area of my brain,” says Ramos.
Proton therapy is more precise and targeted than conventional radiation. It works by using pencil beam scanning, similar to a 3D printer, to match the tumor’s exact shape and size with superior accuracy that eliminates the exit dose of traditional radiation, and spares healthy tissue.
MedStar Georgetown is the first and only proton center in the world to offer the Mevion S250i with HYPERSCAN™ technology, producing beams that are sharper than previous proton systems. Proton therapy with HYPERSCAN is also faster than other proton systems, benefiting patients whose treatment includes holding their breath.
“I am extremely excited to be able to offer this latest advancement, proton therapy, to my patients,” says Brian Collins, MD, a radiation oncologist and clinical director of the new proton therapy center. “It’s clear that this treatment will help to improve the clinical outcomes for our cancer patients and decrease their side effects when radiation is needed.”
“In certain cases, proton therapy can be a game changer,” says Keith Unger, MD, radiation oncologist at MedStar Georgetown. “It allows us to treat cancers where traditional radiation might not even be possible."
How Protons Destroy Cancer
“Proton therapy is an advanced form of radiation that can destroy cancer cells,” says Peter Ahn, MD, a radiation oncologist at MedStar Georgetown. “A machine called a cyclotron speeds up protons to two thirds the speed of light and they become highly charged. These high energy protons are then delivered to the tumor as an invisible beam that eradicates the cancer. Because we can more tightly control the protons than we are able with traditional radiation, proton therapy can be given without damaging critical tissues and structures near the tumor because the beam conforms precisely to the tumor’s size and shape, sparing healthy tissue.”
Advantages of HYPERSCAN™
HYPERSCAN is an FDA-approved proprietary technology that has advantages over existing proton therapy systems. In addition to producing a micro beam that is sharper than many current proton systems and reducing damage to nearby healthy tissue, HYPERSCAN is also faster than other pencil beam scanning systems which can reduce the margin of error in treating tumors that are affected by breathing or organ motion. This improves both treatment accuracy and patient comfort as patients need to spend less time lying still.
“HYPERSCAN is currently the most precise type of proton therapy in the world,” says Dr. Ahn.
“Proton therapy with HYPERSCAN can be given from head to toe,” says Dr. Collins.
Cancer Treatment for Patients with Fewer Side Effects
Proton therapy is beneficial for pediatric cancer patients because it lowers their exposure to radiation avoiding unnecessary exposure to healthy tissue and resulting in less growth impairment as they grow up. Children are less likely to develop a secondary cancer later in life when treated with proton therapy as it treats tumors while keeping health surrounding tissues unharmed.
Proton therapy is also effective in treating re-current tumors.
“There are also certain types of cancer where you have to deliver a very high dose of radiation right next to a critical structure like the spinal cord or brainstem,” says Sonali Rudra, MD, radiation oncologist at MedStar Georgetown. “With proton therapy we can deliver a high dose to the area we are trying to target and minimize the radiation beyond the tumor. So for some patients, proton therapy might be their only radiation treatment option.”
“Proton therapy can also be a good option for patients with left-sided breast cancer, which is close to the heart,” says Dr. Rudra. “When indicated for breast cancer, using proton therapy instead of traditional radiation means more control over the radiation itself and less potential damage to the heart and lungs.”
Proton Therapy Closer to Home and Under One Roof
“The addition of proton therapy is a logical next step for a center like MedStar Georgetown as part of the Lombardi Comprehensive Cancer Center, dedicated to and recognized for providing the latest cancer treatments and access to clinical research trials,” says Dr. Collins.
Lombardi Comprehensive Cancer Center is one of only 49 sites in the nation and the only center in Washington, D.C. to earn the prestigious Comprehensive Cancer Center designation by the National Cancer Institute.
“All the multiple specialties and disciplines involved in cancer care are here helping to support patients through their treatment, in one location, under one roof,” says Dr. Unger. “They no longer have to travel outside of our area to receive this advanced treatment.”
“The addition of proton therapy means MedStar Georgetown offers the full range of radiation treatments for cancer that are available,” says Dr. Collins. “For patients that means we take an individual approach when considering radiation therapy. Whether it’s CyberKnife, proton therapy or conventional radiation, we will choose the optimal treatment to achieve the best outcomes with the fewest side effects.”
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“My surgeon told me he would decide during surgery whether or not I could undergo breast reconstruction immediately, but I’m so glad he decided to wait before proceeding with implants. It gave me a chance to heal, and the results of my reconstruction are just remarkable,” said Sarah Bessin, a 47-year-old breast cancer survivor.
Bessin was diagnosed with breast cancer in July 2015. After she opted to begin breast reconstruction at the same time of her mastectomy in October 2015, Bessin reaped the benefits of undergoing breast reconstruction that combines two tissue-saving technologies to diagnose and avoid serious complications.
The unique combination of SPY Elite and Hyperbaric Oxygen Therapy at MedStar Georgetown saved Bessin’s breast tissue and improved her breast reconstruction outcome. To date, MedStar Georgetown University Hospital is the only center in the Greater Washington, D.C. region offering the combination of SPY Elite and hyperbaric oxygen therapy for patients with breast cancer.
“Everything that we do in plastic surgery involves blood flow. If blood flow is disrupted, skin above it can flake off and even die. This is the reason we need to be able to anticipate those problems intraoperatively so we can act quickly,” says Troy Pittman, MD, Bessin’s breast reconstruction surgeon.
A New Valuable Player in the Operating Room
After a mastectomy, the plastic surgery team enters the operating room with a fluorescent imaging system, SPY Elite. SPY Elite has a long arm that connects to an infrared lamp device, which is used for scanning over a patient’s body. A special contrast is injected through the patient’s IV line, and a TV monitor shows the scans of breast tissue and blood vessels in real time. A breast reconstruction surgeon will move the SPY Elite lamp over different areas of the breast to detect the quality of blood flow in breast tissue before proceeding with the surgery. The system’s monitoring of the blood flow helps surgeons determine if the patient’s tissue is in a safe state to move forward with surgery and place an implant. If blood flow is limited, surgeons will add hyperbaric oxygen therapy after surgery to promote healing in the tissue.
“SPY Elite lets me look at the blood supply of the breast tissue and the nipple in real time. This helps us diagnose a problem early on and initiate hyperbaric oxygen within 24 hours, if we need to,” says Dr. Pittman.
SPYing a Problem
During Bessin’s procedure, the SPY Elite imaging system informed Dr. Pittman’s team that there were worrisome vascular changes in her breast skin following the mastectomy. To avoid compromising the vascular health of the skin, Dr. Pittman decided on a different plan. The new breast reconstruction approach for Bessin meant waiting on the implants and placing tissue expanders, a type of deflated temporary implant, in the surgery site. This plan allows for healing time in the hyperbaric oxygen therapy chamber.
“Our goal is to get patients in for treatment as soon as possible. We are aggressively treating the patient to save their breast tissue and augment their healing,” said Kelly Johnson-Arbor, MD, medical director of Hyperbaric Medicine in the Department of Plastic Surgery. “Our dedicated team of physicians, nurses and technicians works to ensure that patients remain safe and comfortable during their treatment regimen.”
Healing Tissue within Days
Hyperbaric oxygen therapy exposes patients to pure oxygen in a pressurized space. Sending patients to the hyperbaric oxygen chamber treats the initial blood flow issue and can help the patient avoid future healing problems. Although treatment begins within 24 hours after surgery, patients do not have to stay at the hospital. Patients will only visit the hyperbaric oxygen therapy chamber once or twice a day for about an hour.
Bessin’s tissue healed in only 13 hyperbaric oxygen therapy treatments. Her hyperbaric oxygen therapy schedule started with two visits to the hospital per day, which later decreased to one visit per day near the end of her treatment.
“I bounced back quite quickly. I’m already working my normal schedule, and my energy level is back to normal,” said Bessin. “I’m so grateful to my doctors for providing this therapy!”
Treatment Affords Rest and Relaxation Time
Bessin said she spent most of her time relaxing in the hyperbaric oxygen therapy chamber, which is a large glass tube. In the chamber, patients are required to leave most items outside of the chamber to minimize any chance of creating a spark in the oxygen chamber. Patients cannot wear makeup, lotion, nail polish or outside clothing, nor can they bring in cell phones, books or paper. A glass of water and a cotton gown are permitted inside the chamber. During treatment, a nurse or technician stays in the room the whole time to administer the hyperbaric oxygen therapy, answer questions or assist with movie selections.
“Georgetown has a great movie selection!” said Bessin.
Access for Every Breast Reconstruction Patient at MedStar Georgetown
Dr. Pittman has used SPY Elite with hyperbaric oxygen therapy at MedStar Georgetown for five years. For breast reconstruction, Dr. Pittman’s team uses SPY Elite on almost every patient, but particularly in those who want to begin breast reconstruction with an implant immediately after a mastectomy.
“SPY Elite and hyperbaric oxygen therapy allow us to aggressively treat patients safely and predictably,” said. Dr. Pittman. “This approach gives our patients the best chance for success.”
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(Washington, D.C) Kelly Chapman, a school teacherfrom Alexandria, Va., was 33 in the spring of 2016 when she was diagnosed with stage II breast cancer. When she and her physicians decided that the best course of treatment would include a double mastectomy, she was presented with a new reconstruction technique that promised an easier recovery and a more natural-looking result.
“The technique is called the pre-pectoral reconstruction,” says Troy Pittman, MD, Kelly’s plastic and reconstructive surgeon at MedStar Georgetown University Hospital. “I often call it the ‘nearly painless’ breast reconstruction. It has been a game-changer for my mastectomy patients.”
With standard reconstruction after a mastectomy, the surgeon cuts the muscle that sits on the chest wall to create a pouch beneath the muscle in which to insert the implants. “With pre-pectoral reconstruction, we use a purified human skin product that supports the front of the implant and creates an internal bra to support the implant,” says Dr. Pittman.
“The great news about this technique is that in addition to helping newly diagnosed breast cancer patients, I can also go back and revise surgeries I performed the old way in years past,” says Dr. Pittman.
He says recovery from a traditional reconstruction can be very painful and that some women can live with chronic soreness in their breasts for many years after surgery. With the new technique, recovery is easier on the patient.
“I had some discomfort after my procedure but wasn’t in any significant pain,” Kelly recalls. “I had my wisdom teeth out three weeks later, and that was worse than my mastectomy and reconstruction!”
In some cases, physicians can also use the nipple-sparing technique. “Women can hardly tell they’ve had anything done to their breasts,” he says. “With Kelly, we were able to use the technique and give her a real-looking outcome.”
“I was more pleased with my appearance than I ever thought possible,” she says. “I only have a small scar on the underside of each breast, and they are already starting to fade.”
Kelly has been working hard on her recovery, working out each day, stretching and walking, and keeping a positive attitude.
“Cancer has taken away certain things from me, but I get to choose how much ‘cancer sucks,’ and every day I try to find something to be positive about,” Kelly says. “This surgery has been one of those things.”
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Media & Communications Specialist
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For more information about breast reconstruction and the new technique offered at MedStar Georgetown, visit MedStarGeorgetown.org/Prepectoral or call 855-482-6671 to make an appointment.
“I absolutely cannot handle narcotics,” said Cathy Kalimon, after learning that treating her breast cancer would mean surgery and anesthesia.
Cathy received her diagnosis in December 2015 shortly after she and her husband John returned from a getaway in the Shenandoah Mountains. Days later, Cathy met with breast surgeon Eleni Tousimis, MD and breast reconstruction surgeon Troy Pittman, MD. Cathy was scheduled for two surgeries. One surgery included two procedures in the same operation: a bilateral mastectomy with breast reconstruction.
Cathy’s previous surgeries with standard anesthesia left her with unbearable nausea and vomiting. Dr. Tousimis comforted Cathy to let her know she had not forgotten her concern and introduced Cathy to her anesthesiologist.
“When she opened the office door, there he was! Dr. Wonderful!” Cathy said with a chuckle. “Or at least that's what I call him.”
Joseph Myers, MD is the anesthesiologist who developed the ComfortSafe Pyramid®, an alternative approach to anesthesia that can relieve pain without narcotics and their side effects. The ComfortSafe Pyramid® is a checklist that prompts anesthesiologists to consider all the alternative pain relieving choices before a patient regains consciousness after surgery.
Many patients who undergo surgery with ComfortSafe experience:
Awaken more rapidly
A reduced risk of narcotic addiction
Often return home sooner
The ComfortSafe technique was originally developed for the sickest patients in the hospital. Dr. Myers discovered that these sick patients, who could not tolerate standard anesthesia, did not need narcotics.
In February 2016, the American Pain Society published new Guidelines on the Management of Postoperative Pain in The Journal of Pain. The guidelines provide strong recommendations for using a variety of non-narcotic techniques and avoiding opioids when unnecessary. Aligning with these recommendations, the goal of ComfortSafe is to achieve maximum pain relief for all patients, with the fewest number of side effects.
“There are people who are terrified of anesthesia or have had such problems with anesthesia that sometimes they cannot bring themselves to have life-saving surgery. ComfortSafe can help these people make a good decision for their health,” said Dr. Myers. “It’s exciting to see progressive and forward-thinking surgeons willing to collaborate with the anesthesiologists to benefit our patients.”
The collaboration between Dr. Tousimis, Dr. Pittman and Dr. Myers began in 2015 after discussing a research project, which included questions about pain. Together the doctors developed a non-narcotic anesthesia protocol for breast surgery patients.
"I have always had a strong interest in reducing pain after breast cancer surgery," said Dr. Tousimis. “If a patient has a pain-free recovery, they breathe better, get out of bed sooner and have a faster recovery with a better outcome.”
“ComfortSafe is a total game changer and unique to MedStar Georgetown,” added Dr. Pittman. “One of the hardest parts of the journey through breast cancer is loss of control. The nausea, pain and disconnection associated with narcotics is the epitome of that loss of control. Patients simply do not want to feel sick and helpless. With ComfortSafe, all of this is minimized.”
Cathy felt her sense of control return immediately after meeting with her doctors for the first time.
“People hear ‘surgery’ and they automatically expect the worst, but I was so pleased to meet with all the members of my surgical team at MedStar Georgetown,” said Cathy. “I just remember thinking that I was so glad someone was finally going to listen to my concerns about the side effects of narcotics!”
Grateful for a smooth recovery, Cathy encourages patients to ask questions about their anesthesia and anesthesiologists while researching for surgeons.
“My experience with ComfortSafe in comparison to normal anesthesia is like night and day!” she said.
Since ComfortSafe is not limited to breast surgery patients who are in need of an alternative anesthesia method, Dr. Myers looks forward to helping more patients and collaborating with other surgeons. Patients in Obstetrics and Gynecology, Urology and the Wound Healing Center at MedStar Georgetown have also benefited from ComfortSafe.
Physicians do not encourage ComfortSafe on new patients who have never had a negative experience with standard anesthesia. ComfortSafe is recommended to:
Patients who have experienced postoperative nausea and vomiting
Elderly patients who wish to avoid prolonged confusion following anesthesia
Patients who are at high risk for further reliance on opioids
Patients who are morbidly obese with obstructive sleep apnea and use CPAP
Critically ill and oxygen-dependent patients
Dr. Myers has administered anesthesia at MedStar Georgetown for 29 years. His experience helped him sense a bit of fear in Cathy after her last reconstruction surgery.
“I was so afraid of vomiting when I woke up,” said Cathy. “But I think Dr. Myers knew because he didn’t give me much time to think about it. He came right on over to my bed side and confidently said ‘Come on, let’s get up, let’s go’ and, then, he walked me out. I couldn’t believe it. I could really go home and it would be okay!”
Patient Story: Comfort Safe & Breast Surgery – Cathy Kalimon’s Story
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WASHINGTON — A small phase I study provides molecular evidence that an FDA-approved drug for leukemia significantly increased brain dopamine and reduced toxic proteins linked to disease progression in patients with Parkinson’s disease or dementia with Lewy bodies. Dopamine is the brain chemical (neurotransmitter) lost as a result of death of dopamine-producing neurons in these neurodegenerative diseases.
Researchers from Georgetown University Medical Center (GUMC), say the findings, described in the Journal of Parkinson’s Disease, support improved clinical outcomes observed and first reported at the Society for Neuroscience annual meeting in October 2015.
The study tested nilotinib taken daily for six months. A much smaller dose of nilotinib (150 or 300 mg once daily) was used compared to the dose for chronic myelogenous leukemia (300-400 mg twice daily). Twelve patients were enrolled in the clinical trial — one patient withdrew due to an adverse event. Researchers say the drug appears to be safe and well tolerated in the remaining 11 participants who completed the study.
In addition to safety, the researchers also examined biological markers in the blood and cerebral spinal fluid as well as cognitive, motor and non-motor improvement. They found significant signs that nilotinib may provide benefit for patients with these neurodegenerative diseases.
“These results need to be viewed with caution and further validated in larger placebo controlled trials, because this study was small, the patients were very different from each other, and there was no placebo,” says the study’s senior investigator, Charbel Moussa, MD, PhD, scientific and clinical research director of the GUMC Translational Neurotherpeutics Program.
Among the biomarker findings were that:
The level of the dopamine metabolite homovanillic acid — an indicator that dopamine is being produced — steadily doubled, even with the loss of most dopamine neurons. Most study participants were able to stop using, or reduce their use of, dopamine replacement therapies;
The level of the Parkinson's related oxidative stress marker DJ-1 — an indicator that dopamine-producing neurons are dying — was reduced more than 50 percent after niltonib treatment; and
The levels of cell death markers (NSE, S100B and tau) were significantly reduced in cerebrospinal fluid (CSF) suggesting reduced neuronal cell death.
In addition, Moussa adds that it appears nilotinib attenuated the loss of CSF alpha-synuclein, a toxic protein that accumulates within neurons, resulting in reduced CSF levels in both Parkinson’s disease and dementia with Lewy bodies.
The researchers also said that all 11 patients who tolerated the drug reported meaningful clinical improvements. All patients were at mid-advanced stages of Parkinsonism and they all had mild to severe cognitive impairment.
“Patients progressively improved in motor and cognitive functions as long as they were on the drug — despite the decreased use of dopamine replacement therapies in those participants with Parkinson’s and dementia with Lewy bodies,” says the study’s lead author, Fernando Pagan, MD, medical director of the GUMC Translational Neurotherpeutics Program and director of the Movement Disorders Program at MedStar Georgetown University Hospital.
But three months after withdrawal of the drug, participants returned to the same reduced cognitive and motor state they had before the study began, Pagan adds.
Some serious side effects were reported including one patient who withdrew at week four of treatment due to heart attack and three incidents of urinary tract infection or pneumonia. The researchers say these incidents are not uncommon in this patient population, and additional studies are needed to determine if the adverse events are related to use of nilotinib.
“Long term safety of nilotinib is a priority, so it is important that further studies be conducted to determine the safest and most effective dose in Parkinson’s, says Pagan.
The researchers designed the clinical trial to translate several notable observations in the laboratory. The preclinical studies, led by Moussa, showed that nilotinib, a tyrosine kinase inhibitor, effectively penetrates the blood-brain barrier and destroys toxic proteins that build up in Parkinson’s disease and dementia by turning on the “garbage disposal machinery” inside neurons.
Their published studies also showed nilotinib increases the levels of the dopamine neurotransmitter — the chemical lost as a result of neuronal destruction due to toxic protein accumulation — and improves motor and cognitive outcomes in Parkinson’s and Alzheimer’s disease animal models.
“Our hope is to clarify the benefits of nilotinib to patients in a much larger and well controlled study. This was a very promising start,” Moussa says. “If these data hold out in further studies, nilotinib would be the most important treatment for Parkinsonism since the discovery of Levodopa almost 50 years ago.”
He adds, “Additionally, if we can validate nilotinib effects on cognition in upcoming larger and placebo controlled trials, this drug could become one of the first treatments for dementia with Lewy bodies, which has no cure, and possibly other dementias.”
Two randomized, placebo-controlled phase II clinical trials are planned for summer/fall in Parkinson’s and Alzheimer’s diseases. The Translational Neurotherpeutics Program is also planning a small trial in ALS (Lou Gherig’s disease).
According to Novartis, the cost (as of Oct. 2015) of nilotinib for the treatment of CML was about $10,360 a month for 800 mg daily. The dose used in this study was lower — 150 and 300 mg daily.
The phase I study received philanthropic funding and was supported by the Georgetown-Howard Universities Center for Clinical and Translational Science.
Moussa is listed as an inventor on a patent application that Georgetown University filed related to the use of nilotinib and other tyrosine kinase inhibitors for the treatment of neurodegenerative diseases.
Study co-authors include Ellen H. Valadez, MD; Yasar Tores-Yaghi, MD; Reversa R. Mills, MD; Barbara M., Wilmarth, NP; Hellen Howard, RN; Connell Dunn; Alexis Carlson; Sean L. Rogers, MD, PhD; and Ramsey (Drew) Falconer, MD; from the National Parkinson’s Foundation Center for Excellence, the Translational Neurotherapeutics Program, and the Movement Disorders Program at the MedStar Georgetown University Hospital; Michaeline Hebron, and Xu Huang, and Jaeil Ahn, PhD, Georgetown University Medical Center.
The researchers represent the MedStar Georgetown Movement Disorders Program, GUMC’s Translational Neurotherapeutics Program, the Laboratory for Dementia and Parkinsonism, the Georgetown-Howard Universities Center for Clinical and Translational Science Clinical Research and the department of biostatistics.
Marianne Worley Director of Media Relations Office: 703-558-1287 Pager: 202-405-2824 [email protected]
Maryland Woman Celebrates Four Decades of Transplant Progress for Donors and Recipients
(Washington, D.C.) Brenda Hudson’s transplanted kidney wasn’t supposed to function this long.
At the age of 12 in the 1970’s, then Brenda Robinson was diagnosed with lupus that slowly and steadily destroyed her kidneys and caused multiple life threatening health problems. Her face swelled from the massive doses of steroids that kept her alive. She survived a diabetic coma that lasted most of a summer. Brenda’s parents drove her from Upper Marlboro to Georgetown three times a week for exhausting dialysis treatments that were doing the work her kidneys no longer could. When Brenda was about 17 her physicians began to talk about kidney transplant.
“I just remember feeling so sick all the time,” said Brenda. “Kidney transplant was pretty new back then but I wasn’t afraid of it at all if it was going to make me feel better. I said ‘sign me up.’ ”
Testing showed that her 20 year old sister Michelle Robinson Tucker was as close a match possible without being identical twins. After careful preparation, on October 20, 1976 Brenda became the first person ever to receive a kidney transplant from a living donor at then Georgetown University Hospital.
But in recent years, Brenda’s diabetes started affecting her health. She needed heart surgery in March of 2015 and had to start dialysis a year and a half ago as her transplant began to fail. Doctors told her she would need another kidney. The sooner, the better.
“I couldn’t imagine that I would get a second chance for a transplant,” said Brenda. But her husband Dana Hudson turned out to be a compatible donor. And in a surgery very different from the one she had 40 years ago, Brenda received a second kidney on June 28, 2016. In a carefully choreographed set of surgeries, Seyed Ghasemian, MD, laparoscopically removed one of Dana Hudson’s kidneys; Dr. Cooper then transplanted the kidney into Brenda Hudson.
Brenda, Michelle and Dana’s experiences with kidney transplant read like a “then and now” chapter in a medical text book and speak to the history of kidney transplantation at Georgetown - a lesson in how vastly transplant medicine and surgery have improved in the years since Brenda had her first kidney transplant.
The method for Brenda’s transplant in 1976 involved a then standard two-stage process. The first step was the removal of her injured kidneys and her spleen requiring her to immediately begin dialysis treatments. About a month later she received her sister’s kidney in a surgery that lasted several hours.
Since Brenda was Georgetown’s first patient to receive a kidney from a living donor, she remembers having her own isolated wing of the hospital and her own nurse. She was carefully monitored in the hospital for a month.
“When my family came to visit me in the hospital after the transplant they had to dress in these big sterile gowns from head to toe and were so covered up that I couldn’t even recognize who was who,” Brenda recalled. The doctors and nurses were so afraid I was going to catch something to ruin my new kidney. And when I went home from the hospital I had to wear a mask in public for six months. “
“Clinicians were much more heavy handed back then with immunosuppression in those early days,” said Dr. Cooper. “The drugs Brenda would have received were not as targeted as they are now. Today our medications prevent rejection better and have fewer side effects. And our recipients usually go home in about four days.”
“The other nice thing is that today living donors are much more able to see the benefit of their donation. In the old days they might have been taken aback at how uncomfortable they were following surgery,” said Dr. Cooper.
Brenda’s sister Michelle remembers what is was like to donate her kidney back in 1976. She proudly shows off the large scar that stretches about 12 inches from the midline of her abdomen all the way under her right ribcage.
“I would do this all over again for my sister,” said Michelle. “But it was a big surgery as I look back on it. I was in the hospital with some complications for about a month and it took me almost a full year to feel back to normal.”
Dr. Cooper says the old way to remove a kidney from a living donor was to start an incision at the bottom of the rib cage and split the muscles sometimes requiring removing a lower rib to get to the organ, which was painful. Patients were usually in the hospital for 10 days and confined to the home for three to four weeks.
Transplant surgeons needed only four 5mm-1cm incisions to remove Dana’s kidney laparoscopically. He went home two days following surgery.
“I was happy to do this for my wife,” said Dana Hudson. “I just couldn’t watch Brenda be so sick and so debilitated by dialysis.”
“It’s amazing what Dana has done for me. He’s a keeper,” Brenda laughs. “And all these people who donate kidneys are truly special people.”
“Of our approximately 220 kidney transplant we perform each year, 25-30 percent of them come from living donors,” said Jennifer Verbesey, MD, Director of the Living Donor Kidney Transplant Program at the MGTI. “Contrasting to a time when Brenda was the only patient on her wing of the hospital after her transplant in 1976, at the time of her surgery this time, our transplant teams performed six living donor transplants in 36 hours. Some of those happened as a result of MGTI’s Paired Kidney Exchange (PKE) Program in which willing, eligible yet incompatible donor and recipient pairs exchange donors thus allowing both recipients to experience the benefits of living donor transplantation. That’s quite a change in the approach to transplant in 40 years.”
“I’m so thankful for how good I feel all day long,” Brenda said about a week after her transplant. “No more lethargy, nausea, cramping that I felt from dialysis and not have to deal with that anymore is just so unbelievable. And I feel positively wonderful.”
With the help of tutors, Brenda went on to graduate with her class in 1977 from Frederick Douglas High School in Upper Marlboro, Maryland. She then completed a four year degree in food and nutrition at University of Maryland College Park.
After her first transplant Brenda’s physicians advised that she should never become pregnant. Doctors couldn’t predict the stress that carrying a child to term would place on a kidney and what complications her anti-rejection medications would cause to her unborn baby.
“But I was a pioneer there too. I guess I didn’t really listen because ten years after my transplant I gave birth to my miracle baby Bradley and I had him at Georgetown. He’s now 30, big and strong and has always been just fine.”
When asked to compare her two transplant experiences that span 40 years, Brenda laughed. “This one was a lot easier in every way. Mostly, I feel so much better getting this kidney from someone knowing that he didn’t have to go through what my sister went through 40 years ago. There really is no comparison. What hasn’t changed is the wonderful expertise and compassionate TLC I received from all the people at Georgetown, both then and now. ”
Director of Media Relations Office: 703-558-1287 Pager: 202-405-2824 [email protected]
The Heart of the New Cancer Fighting Tool—A 15-ton Proton Accelerator Arrives for Installation
Washington, D.C. (February 13, 2016) -The construction of the Washington D.C. area’s first and only Proton Therapy Center has reached an important milestone. Today the MEVION S250 proton accelerator- the heart of the system that delivers proton therapy to cancer patients- arrived at MedStar Georgetown University Hospital.
The 15- ton superconducting synchrocyclotron, transported from Massachusetts on a flatbed truck, was carefully lowered by crane into its new and permanent home at MedStar Georgetown.
Proton therapy is a highly advanced form of radiation treatment that precisely targets and destroys cancer cells but spares healthy cells. This lowers the risk of side effects to patients, improves their cure rates and reduces the chances of secondary cancers arising later in life.
“We’re very excited to be one-step closer to offering this exciting new technology to our patients with cancer,” said Brian Collins, MD, a radiation oncologist at MedStar Georgetown University Hospital who was on-hand for the historic delivery.
MedStar Georgetown will be one of only 13 centers in the United States to offer proton therapy.
“As one of just 46 Comprehensive Cancer Centers in the United States to earn this designation by the National Cancer Institute, proton therapy was a natural progression for us in terms of caring for our patients with the latest technologies available,” said Dr. Collins who has worked extensively for more than a decade with another advanced radiation technology at MedStar Georgetown; CyberKnife.
“Having proton therapy opens up a whole new population of patients we can treat. Some types and stages of cancer respond better to CyberKnife; others respond better to protons. We are thrilled to offer patients in the Washington, D.C. area both options.”
Dr. Collins says proton therapy will be used for pediatric cancers as well as primary brain tumors. It will also play a role in treating lung, esophageal and head and neck cancers.
Proton therapy is FDA approved and is covered by Medicare and private insurance companies.
As an academic medical center, opportunities will be available at MedStar Georgetown for education, training and research.
With the proton accelerator now in place, the rest of the Proton Therapy Center will be built around it. The Proton Therapy Center at MedStar Georgetown will begin treating patients in about one year.
Director of Media Relations
Pager: 202-405-2824 [email protected]
Washington, D.C., October 7, 2015 – MedStar Georgetown University Hospital has submitted a Certificate of Need (CON) application to the District of Columbia State Health Planning and Development Agency (SHPDA) to move forward with a new $560 million state-of-the-art medical and surgical pavilion to be constructed next to the existing hospital.
The 477,000 square foot pavilion will house a new and modernized Emergency Department with the latest high-tech treatment bays, new operating rooms, surgical and critical care services, new intensive care beds with the latest IT capability, a rooftop helipad and the most advanced imaging services dedicated for emergency and critical care patients. Five levels of the building will be above ground and there will be three levels of underground parking. The project also allows for improved traffic patterns, landscaping and the creation of more green space on the hospital campus.
“This certificate of need is the next step in our journey to completing this much needed medical and surgical pavilion on the Georgetown campus,” said Richard Goldberg, MD, President, MedStar Georgetown University Hospital. “Our goal is to build a medical and surgical pavilion that will meet the needs of our patients, families, staff and community not only today but for years into the future.”
MedStar Georgetown treats a number of complex diseases with services that are not offered at other area hospitals. For example, the MedStar Georgetown Transplant Institute (MGTI) is one of the largest liver and kidney transplant centers in the region with outcomes that exceed the national average. Our well-established kidney transplant program has extensive experience in transplanting even highly-sensitized patients using state-of-the-art technology and is home to an active and growing paired kidney exchange program, giving patients who are otherwise untransplantable, the option of receiving a kidney from a living donor. The MGTI’s Transplant Center for Children is the only facility of its type in the Washington, D.C. region.
Among our Centers of Excellence are national designations in neurosciences and cancer. MedStar Georgetown is the only National Parkinson Foundation Designated Center of Excellence in the District of Columbia. The Lombardi Comprehensive Cancer Center is the only accredited center designated as such by the National Cancer Institute (NCI) in the D.C. area and offers not only a variety of standard oncology treatments but also advanced treatments for complex and difficult to treat cancers, and access to a long list of the latest clinical trials. The Bone Marrow and Stem Cell Transplant Program is the only adult academic program of its kind in the Washington, D.C. area. Patients have access to life-saving treatment options not otherwise available in our region.
To build the new pavilion, MedStar Georgetown has assembled an expert team with extensive local and national experience with conception and construction of similar large projects. The Clark Construction Group has been providing preconstruction services. Trammell Crow Company (TCC) has been providing development management services, HKS Architects is leading the design of the building’s interior and Shalom Baranes Associates (SBA) is the exterior design architect. These firms have unmatched experience in the development, design and construction of healthcare and other large-scale projects.
In addition to constructing the new facility, the existing building will undergo renovations to certain medical and surgical services to achieve more efficient overall hospital operations.
“This exciting new medical and surgical pavilion represents one of the most significant reinvestments in our organization and is absolutely critical to our ability to continue to provide high level, world class care to a community that has depended on us for decades. We continue to work actively and collaboratively with the community and with Georgetown University through the Georgetown Community Partnership so that the result is a top-rate facility that meets a shared vision for the future,” Goldberg said.
The positive economic impact to the District of Columbia is estimated at $1.2 billion.
The targeted completion date is 2020.
Marianne Worley (703)558-1287
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