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Interview with Volunteers

Teresa Singh.

Diagnosed with non-Hodgkin's lymphoma in 1996.

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.'" Beyond Bexxar

In 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."

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Connie McNeal

Diagnosed with Breast Cancer lymphoma in 2001.

In 2001, at the age of 45, Connie McNeal went for her annual mammogram which led to a diagnosis of stage 2 breast cancer. McNeal was not a stranger to cancer. Her father, her mother, a sister, and her grandmother all had two types of cancer. McNeal's doctors recommended a lumpectomy, but after much research McNeal chose to have a radical modified mastectomy.

McNeal became an advocate for herself throughout her care by learning about her various options, but she also has had an impact on many other women because she chose to be part of a clinical trial. Even after her oncologist told her that she fit the criteria for the trail participants, she wasn't sure that she wanted to participate. Then her doctor said, "It will benefit people in the future, and it won't be harmful." McNeal is glad that she made the decision to join the clinical trial. She found that the medical staff went out of their way to make it convenient for her, and she enjoyed knowing that she was making a difference. She says, "It is a wonderful feeling to be of help. Maybe this will benefit my daughter or her generation. The goal is working towards the future for a cure. I'm glad to be a part of that." Throughout her diagnosis and treatment, McNeal was a thorough researcher, and she quickly learned that African Americans are under-represented in clinical studies. She says, "Medicine is geared to the people who are studied." McNeal has become an advocate in other ways. As the President of the Sisters Network® Inc, Flint Affiliate Chapter she is committed to the organization's goal of increasing local and national attention about the devastating impact that breast cancer has in the African American community. Chapters across the country are organized by breast cancer survivors who are committed to establishing much needed community breast health services. Like many breast cancer survivors, McNeal's grandmother was diagnosed with colon cancer after her recovery from breast cancer. Now that she is fifty, McNeal has had and will continue getting colonoscopies for the rest of her life. She knows that early detection of cancer can make a difference. As far as mammograms, McNeal says that they're no fun, but they save lives. She knows.

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