Clinical trials at DF/HCC
Nappier is participating in one of some 350 cancer clinical trials currently under way at the seven institutions that make up the Dana-Farber/Harvard Cancer Center (DF/HCC), including DFCI and the six others described in the story on page 18. Approximately 3,500 adults and children a year join in DF/HCC trials.
"Clinical trials are the only way to move the field of cancer treatment forward. A new therapy is just an idea until it is proven in a clinical trial."
— Richard Stone, M.D., clinical director of the DFCI Adult Leukemia Program
Slightly more than half of the patients enroll in trials that deal directly with new cancer therapies or combinations of treatments. Other studies tackle a wide range of issues, including immune disorders, pain and nausea management, blood testing and measurement, and heart and liver dysfunction. Some fall under broad categories of "quality-of-life" studies, covering prevention and screening, statistics and survivorship, genetic testing and counseling, and analyses of patients' experiences.
Many patients choose clinical trials because conventional treatment hasn't worked, or there isn't a successful standard therapy for their type of cancer. Others are willing to help compare a laboratory-tested new treatment to a standard one, or agree to assist researchers in their specialties.
Stone is quick to note that patients enrolled in clinical trials receive top-quality care. "Care provided in a clinical trial is equal to, or hopefully better than, current treatment," he says. Stringent oversight policies ensure that unexpected side effects or lack of effectiveness in clinical trials are addressed immediately.
Patient Diane Nappier looks on as Richard Stone, M.D., administers an injection as part of her treatment.
Another of Stone's patients, Gerald Best, of New Hampshire, is part of a widely publicized clinical trial. Lack of a matching transplant donor and an intolerance of standard treatment for his chronic myelogenous leukemia (CML) left Best and his wife, Carole, with seemingly one option — check back with Dana-Farber every three to six months to see if any new approach had been developed.
When news of a trial treatment for CML — the drug STI-571 — was publicized on national television, the Bests moved into action. They discovered that Stone, who trained at Dana-Farber with the treatment's creator, Brian Druker, M.D. (now at the University of Oregon), had just become one of the investigators for an expanded trial. STI-571 blocks the enzyme that causes the uncontrolled growth of white blood cells, the hallmark of CML. And, unlike chemotherapy, STI-571 appears to leave healthy cells unaffected.
After taking STI-571 for six months, Best reports minor side effects. He has more energy for his job as a manufacturing manager in a machine shop and activities with his family. "Before I had cancer, I had no perception of what a clinical trial was," says Best. "Even after I got cancer, it was discouraging because none of the available clinical trials would work for me. I feel extremely fortunate to have found STI-571."
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