Clinical Trials & Research
Reducing Radiation Injury
Radiation exposure from nuclear accidents or terrorism can cause mass casualties and pose serious ongoing health threats. Radiation-induced vascular injury (RIVI) is a critical component of the multi-organ failure caused by acute radiation exposure syndrome. RIVI can lead to anemia and thrombocytopenia, as well as cause damage to critical organs especially intestines and lungs. The National Institutes of Health has awarded Chandan Guha MBBS, PhD, a five-year, $2.3 million grant to develop measures to prevent RIVI. In collaboration with Janssen Pharmaceuticals, Inc., Dr. Guha and colleagues will test whether the drug Thrombopoietin Mimetic (TPOm) can protect against vascular injuries caused by radiation. The team will first evaluate TPOm in mice—an effort that will require developing imaging techniques to assess the extent radiation induced normal tissue injury. This effort will have major implications in the diagnosis and management of radiation effects in normal tissue.
Dr. Guha is the Director of the Einstein Institute for Oncophysics, Professor and Vice Chair of Radiation Oncology, as well as Professor of Urology and Pathology at Einstein/Montefiore.
Study Reveals New and More Effective Drug Combination for Aromatase Inhibitor Resistance
Noah S. Kornblum, MD—Montefiore Einstein Center for Cancer Care attending physician and Assistant Professor, Medicine, Einstein—and his team of research investigators presented at the recent San Antonio Breast Cancer Symposium. The team’s Phase II study— identified a new drug combination that may increase survival rates for a common form of breast cancer in postmenopausal women.
Endocrine therapy, often with an aromatase inhibitor, is the standard of care for post-menopausal women with HR-positive advanced breast cancer. Aromatase Inhibitors lower estrogen levels in the body by blocking aromatase—an enzyme that converts other hormones into estrogen.
This hormone therapy prevents the cancer cells from getting the hormones they need to grow. It may also lower the risk of breast cancer recurrence; the likelihood of developing breast cancer in the opposite breast and death from breast cancer, according to the Susan G. Komen® organization. However, overtime most patients develop resistance to aromatase inhibitors. “Treating patients with aromatase inhibitor–resistant disease remains a challenge,” explains Dr. Kornblum, adding that when this happens, thankfully, there are approved agents and drug combinations designed to treat aromatase inhibitor resistance.
Study co-author Della Makower, MD, Attending Physician, Medical Oncology, Montefiore and Assistant Professor, Medicine and senior author of the study Joseph Sparano, MD, Associate Chairman, Oncology Clinical Research, Montefiore, and Professor, Medicine and Obstetrics & Gynecology and Women’s Health, Einstein, worked with Dr. Kornblum to assess the effectiveness of Fulvestrant when given in combination with Everolimus, an mTor inhibitor.
The trial evaluated 130 postmenopausal women with HR-positive, HER2-negative metastatic breast cancer. All participants received Fulvestrant and were randomly assigned either Everolimus or placebo.
After 98 patients had disease progression, analysis placed the median length of time during and after treatment of their cancer that a patient lived but did not get worse at 10.4 months for patients who took Everolimus, compared with 5.1 months among those assigned placebo.
“We were not surprised to find that the combination of Everolimus and Fulvestrant improved progression-free survival compared with Fulvestrant alone,” Kornblum says, “as it follows on the heels of recent study results evaluating similar novel combinations incorporating Everolimus.”
“We caution ourselves to resist the temptation to immediately adopt a positive result of a novel combination from a small study as a new standard of care. Although Everolimus and Fulvestrant is not currently an FDA approved combination therapy for metastatic HR-positive breast cancer, our results suggest this combination could be considered as another promising treatment option for our patients. .
Joshua Stern, MD Awarded Carl W. Gottschalk Research Scholar Grant
You are what you eat or so the old adage suggests, but to what extent? For patients with kidney stones (stone disease) there is a direct correlation between diet and the condition. For some, dietary modifications are not enough.
To further understand the correlation between diet and stone disease as well as find new treatments, Joshua Stern, MD—Attending Physician and Assistant Professor of Urology at Montefiore and our Albert Einstein College of Medicine—is focused on research exploring the link between bacteria in the gut (the gut microbiome) and kidney stones. Dr. Stern has been awarded a prestigious Carl W. Gottschalk Research Scholar Grant from the American Society of Nephrology to further this work.
Through this grant, Dr. Stern's research will seek to determine if a unique gut microbiome in patients with kidney stones (there are differences in the gut microbiome of patients with and without kidney stones) can be isolated and manipulated.
The gut microbiome is so large that it has a direct impact on the various systems within the body and is now considered a separate organ all unto itself.
There are also correlations between the gut microbiome and other conditions, such as diabetes, heart disease, and obesity. If the gut microbiome can be isolated and manipulated to treat kidney stones, the potential exists to develop further treatments for other condition as well.
In collaboration with Einstein researchers Kelvin Davies, PhD and Robert D. Burk, MD, Dr. Stern determined, in a small pilot study recently published in the medical journal Urolithiasis, key differences in the gut microbiome of kidney stone patients compared to patients without kidney stones. They are the first to sequence the gut microbiome in kidney stone patients.
The two-year career development grant will allow Dr. Stern to expand the pilot study to a larger group to further this ground breaking research on the gut microbiome and its impact on kidney stones.
Urology Researchers Seek Innovative Treatments for Spinal Cord Injuries
Sylvia Suadicani and Kelvin Davies—researchers at Montefiore and Albert Einstein College of Medicine—are part of an investigative team that recently received a $1.2 million grant from New York State to advance promising technology for treating paralysis and other effects of spinal cord injuries (SCI). The grant is one of nine totaling $5.7 million announced by Governor Cuomo. The funding will be administered by New York State Spinal Cord Injury Research program and represents the first round of competitive awards since funding was reinstated for the program in 2013.
Clinical Trials Database
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