Patient Studies

Study uses gene therapy as treatment for pancreatic cancer

The use of gene therapy alongside the standard treatment for pancreatic cancer is being studied by researchers at the Elkins Pancreas Center at Baylor College of Medicine and St. Luke's Episcopal Hospital.

"There's no cure for this disease," said William Fisher, M.D., associate professor of surgery in the Michael E. DeBakey Department of Surgery at BCM and director of the Elkins Pancreas Center. "I think that gene therapy is going to be a very important new addition to the standard treatment of surgery, radiation and chemotherapy."

A St. Luke's patient with advanced pancreatic cancer recently became the first person in the Texas Medical Center to begin gene therapy treatment for pancreatic cancer. Other study participants are being recruited.

Pancreatic cancer carries the number one fatality rate of any cancer and is the number four cancer killer in the United States among both men and women. Only about 15 percent are diagnosed early enough for surgery to be possible and the recurrence rate is extremely high. The leading causes of pancreatic cancer are family history, smoking and chronic pancreatitis.

The Baylor/St. Luke's study is one of 20 sites in the country. A total of 330 participants will be enrolled nationally.

To be eligible for the study, participants must be at least 18 years old, not have had previous clots in their legs, have pancreatic cancer that has not spread to the liver, life expectancy of greater than three months and have inoperable pancreatic cancer.

Participants will randomly be assigned to two groups: one group will receive gene therapy in addition to their five-week course of radiation therapy and the chemotherapy drug fluorouracil; the second group will only receive fluorouracil and radiation therapy.

All participants will receive treatment Monday through Friday for five consecutive weeks. Participation in this study will last for up to five years.

Fisher, principal investigator of the study, said he hopes that the gene therapy treatment will shrink the tumors to the point where they can be removed through surgery.

For more information, call 877-PANC-CTR or 877-726-2287.

EEG used to help those suffering from depression

For the millions of adults suffering from depression, finding the right antidepressant medication can be quit a challenge. A study at the Mood Disorders Center in the Menninger Department of Psychiatry at Baylor College of Medicine is using an electroencephalogram to determine earlier whether a patient will respond to antidepressant medication.

"Currently, determining whether a patient will respond to medication is done largely through trial and error," said Lauren Marangell, M.D., director of Mood Disorders Research at BCM and principal investigator for the study. "We hope to develop a simple biologic test to help doctors better understand which patients are most likely to benefit from antidepressant medications."

The trial is recruiting 45 participants between 18 to 75 years old who have been diagnosed with major depression with the most recent episode lasting two weeks or more, and who are not currently on antidepressant medication.

Participants will be evaluated, placed on FDA-approved medication (Lexapro, Wellbutrin XL or a combination) and closely monitored for 13 weeks. EEG monitoring will be done for approximately 18 minutes during seven of the visits. Neither the physicians nor the participants will have access to the EEG readouts until the end of the nationwide trial.

BCM is one of nine medical schools participating in the study. Antidepressant medication and research visits are provided at no cost for the three months of the study and a stipend is available to defray the cost of travel and parking. For more information call 713-798-6663 or e-mail Linda Barloon at lbarloon@bcm.edu.

Study looks at advantages of new breast cancer radiation treatment

A study at Baylor College of Medicine will help determine whether new therapy allows women diagnosed with breast cancer to reduce the time needed for radiation treatment.

MammoSite RTS is a form of partial breast irradiation, which delivers radiation from inside the lumpectomy cavity directly to the tissue surrounding the cavity where cancer is most likely to recur.

After the cancerous tumor is removed, two to three weeks later an uninflated MammoSite balloon is placed in the center of the lumpectomy cavity through a small incision in the breast. The balloon is inflated with a saline solution and remains inflated throughout therapy. The catheter is connected to a computer-controlled machine and a tiny radioactive seed travels into the center of the balloon. The seed delivers irradiation to the tumor site and the area immediately surrounding the cavity for a maximum of 10 minutes.

After five days of MammoSite radiation therapy twice a day, the balloon is deflated and removed from the breast.

"The biggest difference between this treatment and the traditional treatment is that patients don't require six weeks of radiation therapy five days a week," said Kay Blanchard, M.D., BCM assistant professor of surgery in the general surgery division of the Michael E. DeBakey Department of Surgery.

Currently there are no long-term results showing that patients who receive MammoSite partial breast radiation therapy have as good as or better outcomes than those who receive whole breast radiation therapy. A clinical trial at Baylor College of Medicine is studying whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating women who have undergone surgery for breast cancer.

Patients will be randomly assigned to two groups: group one will receive whole breast radiation therapy once a day five days a week for five to seven weeks and group two will receive partial breast radiation therapy twice a day for five consecutive days. In both groups, patients may receive chemotherapy at least two weeks before or after radiation therapy. Some patients may also receive hormone therapy for at least five years.

Patients will be evaluated at one month, and at every six months for five years, and once a year thereafter.

To be eligible for the study women must be at least 18 years old, have undergone surgery to remove the cancerous tumor, not have Paget's disease of the nipple, had no previous radiation therapy to the breast or chest and no previous biological therapy, chemotherapy or radiation therapy for the cancer.

For more information or to enroll in the clinical trial contact Sheri D'Silva at 713-798-8088.

Volunteers needed for study on leg arterial disease

People suffering from leg pain when they walk may qualify for a study conducted at Baylor College of Medicine in Houston.

The study will test a new treatment for intermittent claudication (IC), a condition associated with peripheral arterial disease (PAD) caused by blockages to the arteries that supply blood to the legs. Left untreated, IC can lead to leg amputation. People over 50 who smoke or have diabetes, high blood pressure, or high blood cholesterol are at an increased risk of developing PAD.

The two-year clinical research study, called the WALK Study, will test a gene therapy that could cause new blood vessels to grow from existing ones, enabling intermittent claudication patients to walk with less pain.

Common symptoms of intermittent claudication include pain, cramping or fatigue in calf muscles, thighs, or buttock. Usually, the pain occurs when walking but stops when sitting down. A large percentage of individuals with peripheral arterial disease experience no symptoms. As many as 20 percent of area residents age 65 and over are thought to have peripheral arterial disease, although it is not uncommon to occur in people as young as 50.

For more information on the WALK study, call 713-798-8122 or visit www.WALKStudy.com.