Posts Tagged ‘clinical trials’

Progress and Thanks for Five Years of Phase I Clinical Trials

Phase I AnniversaryPatients.

Clinical trials.

We cannot have one without the other.

The Phase I Clinical Trials Unit at Winship Cancer Institute of Emory University opened in 2009, a time when a significant expansion of clinical trial efforts was underway to support the National Cancer Institute cancer center designation. Over this rapid five-year period, a truly collaborative culture has led to a cutting-edge, early drug development program at a nationally recognized, top 25 cancer center.

None of this has been possible without patients putting their trust in our physicians, nurses, scientists, and many others, to deliver optimal care while asking critical questions about novel drugs and approaches. When I think about the impact of our Phase I unit on patients and their families, I recall a recent conversation with a seasoned oncologist here at Emory. He said, “Donald, if I saw anyone in the chairs here at a store, I wouldn’t know they had cancer.” A simple statement, but one that conveys a number of key messages about how our phase I trials have evolved over five years. Drugs we now have at hand, as a whole, are much safer and better tolerated than conventional chemotherapy. We also have access to more agents with much better activity against cancer, leading to more treatment options.

With improved treatment comes a sense of satisfaction. However, we cannot over-emphasize the critical effect patients have on us as health care providers, researchers, and human beings. As a clinician-researcher, the greatest motivating factor I have is seeing patients do well on trials and coming to visits to talk about trips, family gatherings, important personal events, and the role that treatment on a trial had in helping them live their lives.

For this, we say thank you to our patients and their families for their trust and the courage they show on a daily basis. You keep up your fight, and we will keep up ours.

About Dr. Harvey

R. Donald Harvey, FCCP, BCOPR. Donald Harvey, PharmD, FCCP BCOP is director of the Winship Cancer Institute’s Phase I Clinical Trials section, and Associate Professor of Hematology and Medical Oncology at the Emory University School of Medicine. He is a Fellow of the American College of Clinical Pharmacy and a board certified oncology pharmacist. Widely published in peer-reviewed journals, Dr. Harvey’s research interests include the clinical application of pharmacokinetic, pharmacodynamic, and pharmacogenomic data to patient care.

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Clinical Trials Responsible for Advances in Medical Treatment

Tamara Mobley, 38 and married with 8 and 12 year old sons, has been battling multiple myeloma for five years now under the care of Dr. Sagar Lonial at the Winship Cancer Institute of Emory University. She went on a clinical trial at Winship in order to get the most advanced drug for treating this blood cancer. Because of that trial, the drug is now FDA-approved and is helping Tamara maintain her active life.

Clinical trials are responsible for most advances in medical treatment, but they can’t take place without volunteer participants like Tamara. Unfortunately, there are still many misconceptions about clinical trials that keep people from participating.

For instance, some believe joining a clinical trial is a last resort in the treatment process, which was not the case for Tamara and many other Winship patients. For Tamara, enrolling in a clinical trial was a good option once her standard cancer drugs stopped working.

In the video below, Fox 5 Atlanta talked to Tamara and Dr. Lonial about the decision to participate in a clinical trial.

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It is important to speak with your physician about participating in a clinical trial. For more information about a specific trial, please contact the lead research coordinator.

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5 Actions to Consider When Diagnosed with Cancer

5 Things to ConsiderA common symptom of a new cancer diagnosis is pure and utter bewilderment. The American healthcare system can be a confusing maze involving dozens of options and decisions. Helping someone understand what comes next is an important part of my job as an oncologist and is necessary to assure a patient’s overall wellbeing.

Here are five actions to consider taking after receiving a cancer diagnosis.

  1. Get a second opinion. Before starting any cancer treatment, get at least one additional physician or team of physicians to review your case and give an opinion on both the diagnosis and possible treatment options. In fact, you may be required to get a second opinion by your insurance company. Don’t worry about offending your doctor. Getting a second opinion is a very common practice.
  2. Look for a clinical trial. Tens of thousands of people benefit each year from volunteering to participate in a clinical trial. Clinical trials can provide you with access to treatments not otherwise available, including new drugs and therapies for many types of cancer. Winship Cancer Institute is proud to offer patients access to hundreds of cancer clinical trials.

Canine Brain Tumor Trial Shows Promising Results!

Petey cancer clinical trialFox 5 News health reporter Beth Galvin features the first “patient” in a Brain Tumor trial that combined surgery with a new experimental agent. Petey, a dog, is a part of a research trial aimed at translating new brain cancer therapies to humans by assessing results in dogs with similar diseases.

Winship Cancer Institute of Emory University neurosurgeon, Costas Hadjipanayis, MD, PhD, developed the experimental agent in his Brain Tumor Nanotechology Laboratory. Petey’s tumor was partially removed in surgery at the University of Georgia (UGA) College of Veterinary Medicine, and the new, investigational drug was infused directly into the tumor area. Now, 15 months later, his tumor has shrunk and Petey is seizure-free and doing well. Watch the full story here:

 

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Can a CT Scan Save 32,000 Lives? The Answer May be ‘Yes’

Lung CT ScanWhat if there were a way for 32,000 of the 160,000 lives lost each year related to cigarette smoking to be saved? There may just be. Findings from a recent study show the risk of dying from lung cancer could be reduced by 20 percent by use of a low-dose helical computed tomography (CT) scan. In other words, this type of CT screening could save over 30,000 lives a year.

Lung cancer is the leading cause of cancer-related deaths, and as such, cancer research and treatment experts are constantly looking for ways to reduce the pervasive nature of the disease. The National Cancer Institute (NCI) launched the multi-center National Lung Screening Trial (NLST) in 2002. The trial compared two ways of detecting lung cancer using low dose helical (spiral) CT vs a standard chest X-Ray. Part of this research study was actually led at Emory by radiologist and researcher Dr. Kay Vydareny.

The trial aimed to determine the effects of low-dose helical CT scans vs chest X-Rays on lung cancer death rates in high-risk populations. Both chest X-rays and helical CT scans have been used as a means to find lung cancer early, but the effects of these screening techniques on lung cancer mortality rates had not been determined.

Over a 20-month period, more than 53,000 current or former heavy smokers ages 55 to 74 joined NLST at 33 study sites across the United States. In November 2010, the initial findings from NLST were released. The conclusion? Clinical trial participants who received low-dose helical CT scans had a 20 percent lower risk of dying from lung cancer than participants who received standard chest X-rays.

While the benefits of low-dose helical CT scans in the reduction of lung cancer deaths are obvious, not every diagnostic option comes completely risk free. The CT scans can occasionally detect suspicious abnormalities that do not turn out to be lung cancer – known as false positives. Many of these abnormalities are scars from smoking, areas of inflammation or other noncancerous conditions that may require additional testing to determine that they are not harmful. These tests have been known to cause undue anxiety for patients and may sometimes lead to biopsies or surgeries.

“It is certainly an individual’s choice whether they want to be screened for lung cancer with a CT scan if they have no symptoms. However, it is important to make certain that such individuals have complete information and be well-informed before having such a scan. If a patient has symptoms, such as a persistent cough, weight loss, persistent hoarseness or trouble breathing, he or she should see a physician as soon as possible. Often these symptoms are due to something other than lung cancer, but more tests should be performed to make certain,” says Vydareny.

What should a person at high-risk for lung cancer do? The answer that all physicians agree on is to stop smoking right now, the sooner the better. Or even better … don’t start smoking ever, further reducing the chances of getting cancer or suffering from a stroke or heart attack as well.

“All physicians hope that there will be a test that can screen for early lung cancer and that the dismal prognosis of those with lung cancer will improve. Perhaps it will be screening with CT scans. Perhaps it will be a blood test,” says Vydareny. “That day hopefully will come, but it has not yet arrived. But if you are or have been a heavy smoker, your first step should be to consult your primary care physician to discuss all possible screening options.”

For more information, check out the lung cancer screening clinical trial video below: