From Patient to Participant
Each year, 15 percent of new patients at the Cancer Center choose clinical trials. Here's why.When Teresa Singh was diagnosed with non-Hodgkin's lymphoma in 1996, her oncologist recommended the standard course of treatment: a combination of chemotherapy and radiation.
But in researching her disease, Singh learned the likelihood of her cancer returning within 18 months was high. And if a recurrence was treated successfully, it was still likely to come back yet again.
Standard treatment just didn't seem like the right choice for Singh, whose sons were 2 and 7 years old at the time. So she started looking for other options.
"I asked right away about alternatives, but I didn't know what that meant really," Singh said. "I was interested in what was being offered in specialized centers around the country, but I didn't know what I needed was right in my backyard.".
The right choice for Singh was a clinical trial. Clinical trials allow patients access to potential new therapies, while providing researchers an opportunity to develop better ways to treat cancer.
In 2006, 893 patients enrolled in 247 clinical trials at the U-M Comprehensive Cancer Center. The trials span the gamut of cancer care, from new methods of prevention to better means of treatment.
"Clinical trials are the bridge between the researcher's laboratory and real-world clinics," said David Smith, M.D., director of the Cancer Center's Clinical Trials Office. "We can do lots of things to cure cancer in mice, but until we test these methods in a rigorous fashion in people, we don't know."
Meeting Dr. Kaminski
When Singh came to the Cancer Center 11 years ago, Mark Kaminski, M.D., a U-M professor of medicine, was working on a study to determine the effectiveness of a new drug he and his colleagues had developed to treat lymphomas. It took a remarkably different approach than chemotherapy: The drug targeted cancer cells specifically, delivering radiation to them while avoiding normal tissue.
After doctors determined that Singh's form of cancer made her eligible to participate in a trial to test the experimental drug's effectiveness, Singh was admitted to University Hospital for a few days so that Kaminski and his team could monitor her carefully. She received two injections of tositumomab and iodine I131 tositumomab.
On the day after the second injection, Singh could tell by looking at the bulge in her abdomen that her tumor was shrinking. Subsequent CT scans confirmed it: Her cancer was in remission -- and still is more than a decade later. In 2003, the U.S. Food & Drug Administration approved Kaminski's drug -- known commercially now as Bexxar -- for the treatment of some cases of low-grade non-Hodgkin's lymphoma.
"The great thing is that Bexxar wasn't the end of the story," Kaminski said. "The future is looking incredibly bright. When a lymphoma patient comes to me and says, 'My doctor just told me that I have an incurable disease,' I tell them, 'Don't give up.'"
The patients we talked to stressed that building a strong relationship with their health-care team was important in their decision to choose a clinical trial. The key to building that relationship is open, honest communication. Think about starting the conversation with these questions:
- What is the goal of the study? Cure? Control? Prevention?
- Why do you think this drug or therapy may be effective?
- What are the risks and benefitsboth short- and long-term?
- What kinds of tests will I have? Will my insurance cover this?
- How will this impact my daily life?
- Can I talk to others who have participated?
Beyond BexxarIn many ways, Bexxar is the ultimate example of the good that can come from clinical trials. Working in partnership with doctors, patients who are willing to take a calculated risk are helping to develop better ways to treat cancer.
In cancer clinical trials, the goal is often to determine whether a new treatment method works better than the existing standard of care, Smith said. Patients never receive a placebo, or sugar pill, when an effective treatment exits for their cancer. Instead, researchers may seek to determine whether a new drug in combination with standard care is more effective than the standard alone.
All trials are strictly controlled by federal regulations to ensure patient safety. An Institutional Review Board made up of physicians and scientists as well as patients and other members of the community reviews every study to make certain they are well designed, ensure patient safety and do not incorporate unnecessary risks. In addition, at the U-M Cancer Center, investigators meet weekly to discuss patients who are enrolled in clinical trials.
"No trial is done here without a lot of people looking over investigators' shoulders," Smith said.
The first priority is always to determine what options are in the patient's best interests, Smith said. From there, if a patient decides a clinical trial is the best option, the health-care team provides a full explanation of what will be involved in the clinical trial and answers questions. A consent form documenting the details of the trial -- including the study's approach, the therapy to be tested, possible risks and benefits, and necessary tests -- is provided so patients can discuss their decision with family and friends before signing on to participate.
Patients can decide at any time to withdraw from a trial. Since enrolling in the initial Bexxar study, Singh has participated in several other trials to assess the drug's long-term effects.
"I always volunteered. I knew I could say 'no,' or 'that's enough,'" Singh said. "Actually, I felt like I was part of a team."