West Virginia has a long history of being on the medical forefront. In fact, the first person ever treated with a full course of penicillin was being treated at Fairmont General Hospital in 1944. With a foundation in medicinal research, the Mountain State maintains a tradition of excellence in medical research and patient care by continuing to participate in important clinical trials.
Here we take a look at five West Virginia hospitals that are currently participating in clinical trials relating to traumatic brain injury, lung cancer, leukemia, orthopedics and breast cancer.
Charleston Area Medical Center
The brain is one of the most complex and frustrating parts of the body for doctors to treat. Aside from all of the functions of the body the brain controls, it also has the power to self-destruct.
Researchers at Charleston Area Medical Center (CAMC) are participating in a nationwide clinical trial to see if a new drug can help slow the spread of damage to the brain.
The investigational drug is being developed by Neuren Pharmaceuticals Limited, a biopharmaceutical company, in conjunction with the U.S. Army. It has been shown to reduce brain damage and improve recovery after traumatic brain injury in animal studies.
Once a brain injury occurs, a process begins in which the brain starts turning off neurons and sometimes ends with the brain self-destructing or killing itself.
“We’re hoping this drug is the solution to turn off that process,” says Frank Lucente, M.D., a trauma surgeon and principal investigator at CAMC. “We can’t bring back the cells from the original injury, but we can hopefully turn off the biological machinery and stop the brain from killing itself.”
Traumatic brain injury is a very serious health problem that frequently results in persistent problems with memory, attention span and mood. Severe cases can cause fatigue, seizures, inappropriate behavior, visual defects and the loss of smell or taste.
“This is important because traumatic brain injury is a devastating injury,” Lucente says. “It can take someone and make them dependent on others. It can be especially devastating in young people.”
Previous safety studies done with healthy male volunteers have shown a good safety profile for the investigational drug. This is the first study to look at the drug’s safety in traumatic brain injury patients. Researchers are looking for male patients between 18 and 70 years of age that are admitted to the hospital with a non-penetrating moderate to severe traumatic brain injury.
Researchers hope to enroll about 10 participants in the trial from CAMC. The long-term goal of this study is to provide physicians with a safe and effective treatment for traumatic brain injury.
“As a physician, it’s frustrating,” Lucente says. “We spend a lot of time in the intensive care units managing the patient’s oxygen and blood levels to prevent more injury, but the bottom line is that the brain is unpredictable. It is amazing the advancements we have made in medicine, but there are currently no drugs available to reduce the brain damage or the persisting symptoms that result from traumatic brain injury.”
Researchers are hopeful that this investigational drug will prove to be effective and possibly transform the standard of care for brain injuries.
Davis Health System
Davis Memorial Hospital’s (DMH) Cancer Care Center is one of only 59 sites worldwide selected to participate in a new lung cancer vaccine trial, according to Dr. Donald Fleming, a hematologist and oncologist at DMH’s Cancer Care Center. “This is an exciting development and the result of over a year’s work in securing this opportunity.”
Patients with non-small cell lung cancer, which makes up approximately 85 percent of the lung cancer cases nationwide, now have the opportunity to participate in the vaccine trials for Lucanix, a genetically engineered cancer vaccine that is currently in the final stages of clinical trials.
“We are proud that the Cancer Care Center was chosen to be involved in this important study,” Fleming says. “This is the first lung cancer vaccine trial to be offered to patients in this area. For this particular study, the next closest site is in Canton, Ohio.
“Non-small cell lung cancer is associated with both smokers, which we unfortunately have a large population of in this area, and non-smokers, especially women,” he explains. “Although patients will need to fulfill certain requirements to be able to participate in the study, we know most patients who do qualify will be willing to do so.”
This randomized Phase III trial is studying vaccine therapy to see how well it works compared with a placebo in treating subjects with Stage III or Stage IV non-small cell lung cancer. The trial involves receiving an injection once a month. This is a double-blinded study, meaning neither the physician administering the injection nor the patient knows whether he or she is receiving the vaccine or a placebo.
“The Lucanix vaccine is designed to assist with the prevention of the cancer’s progression,” Fleming explains. The trial will evaluate the ability of Lucanix to significantly prolong the overall survival of patients when compared to best supportive care. It will also evaluate other endpoints, including quality of life, progression-free survival, time-to-progression, tumor response, response duration, the development of brain metastases and overall safety.
“My hope is to be able to take care of every eligible patient,” Fleming says. “I’ve found that cancer patients have an incredible desire to help others. Even if participating in this trial doesn’t affect their own cancer, they want to do something that may, in the long run, improve the quality of life for others.
“In addition, the patient is not responsible for any costs related directly to the trial, including the medication itself,” he adds.
The qualification requirements for participants include being between the ages of 18 and 75, having a confirmed diagnosis of non-small cell lung cancer and having a stable disease or a partial response or complete response to a chemotherapy regimen. There are additional eligibility requirements that can be discussed with a clinical professional.
Marshall University
At Marshall University and the Edwards Comprehensive Cancer Center, researchers think the next line of defense in the fight against some cancers might come from the bodies of creatures with fins and gills.
Dr. Oscar Ballester, an oncologist, and Dr. Elaine Hardman, a biochemistry researcher, are conducting a clinical trial to see whether omega 3 fatty acid supplements from fish oil can prevent certain types of leukemia or delay their reaching a stage that requires treatment.
Specifically, they are studying the supplement’s effects on chronic lymphocytic leukemia, monoclonal gammopathy of undetermined significance and smoldering multiple myeloma.
“This supplementation changes some of the programs the cancer cells have to survive and multiply,” Ballester told The Herald-Dispatch. Ballester and Hardman are trying to determine whether omega 3 supplements will benefit patients either when used alone or with other treatments.
“At this point, patients have taken this supplementation and we are looking at the leukemic cells to see if we can demonstrate a favorable change,” he says. They are also testing the cells in the test tube to see if they become more sensitive to chemotherapy. Although the study will not be completed until December 2011, they already have published findings that will aid other researchers studying the effects of omega 3 supplementation.
The omega 3 trial is one of more than 100 clinical trials approved by Marshall’s Institutional Review Board, which evaluates all proposed trials to ensure they include strong protections for the patients who participate. Current studies explore new diagnostic techniques or treatments for diseases ranging from cancer and HIV infection to heart disease and diabetes.
Because Marshall and the cancer center are members of extensive clinical trial networks, such as the North Central Cancer Treatment Group based at the Mayo Clinic, eligible patients have access to hundreds of additional clinical trials. Whether they begin locally, as the omega 3 trial did, or originate from other medical centers in the networks, clinical trials give local patients access to promising treatments that may not otherwise be available.
In addition to benefiting the individuals who participate, such trials play a vital role in advancing medical treatment, according to Dr. Charles McKown, Jr., the dean of Marshall’s medical school.
“The carefully structured and implemented clinical trials format employed in our country to establish the efficacy and safety of therapeutic regimes represents the very best possible means of assuring authenticity while simultaneously guaranteeing utmost patient safety,” McKown says.
Stonewall Jackson Memorial Hospital
Dr. Shafic Sraj, the orthopedic surgeon and shoulder, elbow and hand surgery specialist at Stonewall Jackson Memorial Hospital in Weston, is conducting a clinical trial with the goal of standardizing the assessment of a patient’s shoulder function. Providing a standard is important so that all the interested parties—physicians and patients—can communicate easily. Sraj’s assessment strategy, Plumbline Behind the Back, measures the shoulder’s internal rotation.
In the area of shoulder surgery, measurement of shoulder motion, specifically internal rotation, has proven difficult to standardize. The commonly accepted measurement has been the hand-behind-back method (HBB). This method, though highly popular, easy to use, easy to teach and endorsed by the American Academy of Orthopedic Surgeons and the American Shoulder and Elbow Surgeons, is a weak link in the examination of shoulder range of motion.
Sraj explains the problem by saying, “Several recent studies have challenged the accuracy and duplication of this measurement among different observers. Limitations in the thumb, wrist, forearm and elbow motion make accurate application of the HBB method challenging as it greatly underestimates the contribution from other joints.”
He continues, “It is our aim to improve on the technique of HBB by eliminating some of the factors impacting it. First, we eliminated the use of visual estimation and use angular measurement instead. Second, we eliminated the effect of the wrist and thumb. We use the angle between the forearm and the horizon instead.”
The key to evaluation of the usefulness of this measurement technique is to document its reliability. Sraj is recruiting a group of volunteers who have no shoulder pathology. Repeat measurements are made for each arm by different examiners and at different times. Results are then compared. The end results would be a range of normal values and the correlation coefficients (measures of reliability and reproducibility).
Sraj hopes this new tool will help make shoulder evaluation more reliable, reproducible and clinically relevant. It will also help monitor patient progress, as one of the common sequalae of shoulder problems is not being able to reach behind one’s back as when tucking in a shirt or fastening a bra.
West Virginia University
More than a dozen patients diagnosed with triple-negative breast cancer have received treatment through a novel clinical trial at the Mary Babb Randolph (MBR) Cancer Center at West Virginia University (WVU) in the past year. While the center’s medical director, Jame Abraham, M.D., has seen evidence that the drug treatment shows exciting preliminary results, he says it’s the trial process that is important evidence of what West Virginians need.
The trial’s participants travel from various parts of West Virginia, including Beckley, Parkersburg and Charleston, as well as from neighboring Ohio and Pennsylvania, to receive treatment for the aggressive breast cancer that historically doesn’t respond well to drugs used to treat the majority of breast cancers.
Abraham, the Bonnie Wells Wilson Distinguished Professor and Eminent Scholar in breast cancer research at the MBR Cancer Center, is working with oncologists from Charleston, Huntington, Fairmont, Clarksburg, Martinsburg, Wheeling and other parts of the state to build a clinical trial network for the state. It may cost between $2 and $3 million to build the clinical trial infrastructure, but the network would bring new and advanced drug treatment opportunities to cancer patients within their own communities.
“Many rural states are finding this is the only way they can attract new treatments to their community,” Abraham says. “We recognize we need to work together.
“The number one reason our patients leave the state is that they are looking for new treatments for cancer,” he adds. “They should be able to get that within their own community.”
A consultant is helping the group research models in other states and will assist them in drafting a concrete business plan. In the meantime, Abraham says organizers have agreed to form a 501(c)3.
The MBR Cancer Center’s triple-negative cancer clinical trial participants have begun to show signs of improved health, with a number of patients showing tumors that have shrunk or disappeared. This type of breast cancer accounts for 10 to 15 percent of nearly 200,000 cases diagnosed in the United States each year. Through the trial, patients are being treated with a combination of two standard chemotherapy drugs, with a new class of drugs targeted for triple-negative to beat the cancer.
Abraham says he hopes the drug will be approved and made more widely available to those who need it. He looks forward to the future when West Virginians won’t have to weather the emotional and financial toll of traveling to other cities for treatment.
“The only way to make significant progress in cancer treatment is by conducting clinical trials,” he says. “Today’s clinical trial patients are making it better for tomorrow’s cancer patients, and I learn every day from the courage they show.”
