Not everyone helping to advance medical knowledge at the University of Minnesota is a researcher, physician, or nurse. Some of the most important contributors to health research are the patients who participate in clinical research studies.
They are not only learning about and getting access to leading-edge medical treatments, says Linda Carson, M.D., chair of the Department of Obstetrics, Gynecology, and Women’s Health, “these women are contributing to the growth of scientific knowledge,” she says. “It’s altruism.”
The process of bringing a promising new treatment from the lab to the market is lengthy and involved. Before a treatment can be made available to patients, it must be tested through clinical research with human volunteers. According to the Food and Drug Administration (FDA), clinical research is designed to study prevention options, new treatments or new ways to use existing treatments, new screening or diagnostic tools and techniques, and options for improving quality of life for people with serious medical conditions.
Not every patient with the disease that’s being studied in a given trial is eligible for inclusion, however; researchers set specific criteria for participation. Those criteria often include age, type and stage of disease, previous treatment history, and the ability to manage the logistics of the clinical trial.
June LaValleur, M.D., associate professor in the department, acknowledges that participating in a research study can sometimes be time-consuming. “You’ve got to find time to come in for frequent visits and sometimes find time to keep a diary,” she explains. For that reason, most participants in the University’s clinical studies live in the Twin Cities area.
While there’s a degree of risk involved in any clinical trial, the advantages can be well worth it, Carson says. Clinical trial participants are able to take an active and informed role in their own health care. They have access to up-andcoming therapies, as well as expert care from specialists who are leaders in their field.
“Most women, if offered a chance to participate in a trial that might improve their chances for survival, will be eager to do it,” Carson says.
Improving survival rates
Carson recently wrapped up a Phase I trial to establish the safe dosage of two chemotherapy drugs, topotecan and cisplatin, when used together with radiation therapy to treat cervical cancer. Topotecan and cisplatin make tumor cells more sensitive to radiation, and the hope is that the drug combination improves survival rates for cervical cancer patients. Eighteen patient volunteers participated in Carson’s study.
Most Phase I trials are aimed at determining the maximum tolerated dose of a promising treatment. That generally involves increasing the amount of the medication given to patients until they encounter dose-limiting side effects, Carson says.
Help for low libido
LaValleur has led a few clinical trials over the years, but her recent testing of a propitious new treatment for hypoactive sexual desire disorder, or low libido, in menopausal women was unique in some ways.
“This was the easiest study I’ve ever recruited for,” LaValleur says. “Women are just wanting help. The FDA has not approved anything for sexual dysfunction in women… There is a device, but it doesn’t work for everyone.”
She’s hopeful that her recent study will be a big step toward changing that. The treatment she tested was a testosterone patch designed to enhance sex drive. Doctors have prescribed testosterone, which is known to increase sexual desire, in other forms—injections, creams, and gels—but it’s harder to regulate dosage when it’s administered in those ways, she says.
LaValleur’s study offers the possibility of a safer and more effective delivery route. Its outcome was hopeful, she says; participants were having more frequent sexual encounters with their partners and reported no serious side effects.
A tried approach for a new cancer
Gynecologic oncologist and assistant professor Melissa Geller, M.D., talks enthusiastically about the clinical research she’s collaborating on with Jeffrey Miller, M.D., in the Department of Medicine involving natural killer (NK) cells as weapons against ovarian cancer.
“It’s really exciting, and it’s different from anything we’ve ever done before,” Geller says.
The study’s premise is that NK cells from related donors—parents, siblings, or children who are at least 14 years old—can be used to stimulate a patient’s own immune system to fight the cancer. The cells are harvested from donors fairly easily, in a process Geller likens to donating blood, and then infused into the patient.
In this case, Geller is studying the treatment’s effectiveness in treating advanced, recurrent ovarian cancer. The principle is being tested in other ongoing University studies on blood and bone marrow cancers and breast cancer.
Four patients are currently enrolled in the study, and Geller hopes to have 10 in the next year. She’ll follow their progress for another year while refining the way the treatment is given.
Patient volunteer Angela Cabrera said participating was a fairly easy decision for her. She had tried three forms of chemotherapy to treat her ovarian cancer, none of which yielded good results. “There are no really great options for treating my ovarian cancer,” she says.
Plus, the concept behind the study is intuitive, Cabrera adds. “It just makes sense. Some people aren’t risk-takers, but [this study] presents a relatively low risk. And I almost always find that good things happen when I take risks.”
Having a physician she likes and trusts in Geller makes all the difference in deciding to participate in the study, as well.
“She knows me and is looking out for my best interests,” Cabrera says.