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Medical Studies Are Making Strides Along First Coast Almost 400 Trials Are Being Conducted to Study Treatments for Medical Conditions.

Posted on: Friday, 21 October 2005, 18:00 CDT

By JESSIE-LYNNE KERR

For some, it's about hope.

For others, it's about the lack of it.

Regardless of the reasons, the region is a fertile ground for clinical studies. Almost 400 trials are being conducted in Jacksonville to investigate treatments or experimental drugs for a variety of diseases and conditions, according to the U.S. National Institutes of Health.

Michele Uhrig is one of the thousands who have volunteered over the years to take part in such experiments.

This summer, she was doing what a lot of 22-year-olds do: going to college and working part-time at a discount store.

Then she scratched the base of her neck and felt the elongated lump that changed her life.

"It didn't hurt or anything but it was just weird," she said.

A scan showed Uhrig had a mass from her neck into her chest and around a part of her heart. The diagnosis was Hodgkin's disease, a malignant disorder of the lymphoid tissue.

Uhrig was referred to the Baptist Cancer Institute and to Troy Guthrie Jr., a hematology oncologist, who has been involved in clinical studies for 34 years.

Guthrie put Uhrig into one of 82 clinical studies in cancer and hematology being conducted at the Baptist Cancer Institute.

Nearly 500,000 new cases of Hodgkin's disease are diagnosed each year with about 30,000 of them in the United States, he said.

After the 12-week treatment period of chemotherapy, oral medication and radiation, Uhrig will get periodic checkups for 10 years.

"I was really bummed to learn I had Hodgkin's," Uhrig said, "but I feel lucky to be alive and part of a study. I may help the doctors find a way to test small children to prevent this, and that would be wonderful."

People who go on clinical studies do better than those who don't, Guthrie said, adding that it is important that people understand they are not guinea pigs when they agree to join studies. "They are offered treatment that we believe will be to their benefit. I don't do studies I don't think are good for people. We would not be where we are in medicine without them."

Michael Joyce is a pediatric hematology oncologist at Nemours Children's Clinic. As chairman of Baptist's Institutional Review Committee, he reviews the 300 clinical protocols being tested at Baptist, Wolfson Children's Hospital and Nemours.

"The rewards of this work are seeing children actually cured who grow up to lead productive lives," Joyce said.

Thanks to clinical studies and research, he said, more than 70 percent of childhood cancers can now be cured.

Acute lymphocytic leukemia, the most common cancer in children, had a cure rate of only 4 to 5 percent in 1960, but now it's 80 to 85 percent, he said.

"That's a direct result of pediatric oncologists getting together nationally and forming children's cancer study groups to participate in these trials," Joyce said. "We have learned so much and we owe a debt of gratitude to those patients and their parents who have made this progress possible."

Mayo Clinic Jacksonville has a number of clinical studies seeking new ways and drugs to treat cancers, neurological conditions and diseases, said Robert Smallridge, Mayo's research director and deputy director of its cancer center.

"Our lab-based investigators work with the clinicians, and we are really strengthening cancer research with many studies," Smallridge said.

Florida is a fertile field for clinical studies, Smallridge said, because of its aging population. "The majority of medical problems occur as we get older," he said.

Physicians involved in clinical studies network with physicians throughout the area to keep them aware of what is in the medical research pipeline so they may refer their patients as possible candidates, Smallridge said.

"For instance, for a thyroid cancer study, we sent letters to all the endocrinologists in the state and the region so they may refer patients," Smallridge said. "We, in turn, refer our patients to other studies."

To the physician, a great achievement is to see a patient get more years of a quality life. In some cases, Smallridge added, that can even be a dramatic improvement in the quality of their life.

"If a patient has an illness and doesn't appear to be on a treatment that is working," Smallridge advised, "ask the doctor if there's a clinical study they might join."

Much of the day-to-day work in clinical studies is done by clinical research coordinators such as Ellen Miceli, a graduate nurse for 30 years, the past dozen at Mayo where she's been in clinical studies for five years.

"This offers a different kind of nursing opportunity," Miceli said. "There is tremendous satisfaction when a drug actually works. Sometimes we have people with few options and it is gratifying when you can actually help them."

Of course, there are downsides, also.

Alan Berg, 62, a retired Tallahassee lawyer recognizes the odds against him. He was diagnosed more than a decade ago with primary sclerosing cholangitis, a rare, slowly progressing liver disease than can lead to cancer.

He was treated for a while by a specialist at Shands at the University of Florida, but that doctor left. Berg's sister recommended he go to Mayo Clinic Jacksonville, where just over two years ago he joined a four-year trial of a new drug.

In addition to taking the daily medication provided by Mayo, Berg travels to Jacksonville every three months for blood tests and once a year for a physical examination. Miceli checks on him by telephone every month.

"The only other treatment for this disease is a liver transplant. There have been other drug trials, but they have not worked," Berg said. "I was happy to get into something that not only might help me, but help others." jessie-lynne.kerr@jacksonville.com, (904) 359- 4374@To search for clinical studies being performed for various illnesses, go to clinicaltrials.gov.AREA RICH IN STUDIESThere are almost 400 clinical studies being conducted in the Jacksonville area, according to the U.S. National Institutes of Health. Some of them:-- A trial of exemestane vs. continued Tamoxifen in postmenopausal women with early breast cancer-- A drug study for adults with insomnia-- Irinotecan and Docetaxel in treating patients with metastatic pancreatic cancer-- Hand hygiene studies-- Treating unresectable Stage III or Stage IV malignant melanoma-- Alzheimer's Disease Neuroimaging Initiative

Source: Florida Times Union

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