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Finding Hope in Science
Phase 1 clinical trials offer options when standard treatment isn't a choice
A little more than eight years ago, Diana Tarnacki was diagnosed with ocular melanoma. It hadn't spread beyond the eye, so she opted for plaque radiotherapy, a unique type of radiation therapy for people with eye tumors. Specialists at the University of Michigan Kellog Eye Center attached a thin piece of metal lined with radioactive seeds to the wall of her eye. The procedure destroyed the tumor.
But her doctors warned her that the melanoma could come back. And in April, it did. Scans showed the melanoma had spread to her bones and possibly her liver and lungs as well. Her oncologist explained that she had run out of standard treatment options. But she might qualify for a study that would give her access to the latest potential therapies for cancer. She talked it over with her husband, Bill, who was as anxious as Diana to find another possibility for treatment. Diana accepted the offer.
"It's difficult to hear that there's nothing more they can do, so you look for something you can do anyway," she said. "This study sounded like something that had potential. And I didn't want to be sorry that I didn't try what I could try to fight it."
The University of Michigan Comprehensive Cancer Center recently launched a new initiative to speed promising therapies from the laboratory to the clinic -- where all patients may eventually benefit. In the meantime, however, part of the core mission of the newly established Ravitz Foundation Phase I/Translational Research Center is to offer new opportunities to patients who have no other options.
Phase I clinical trials are the first step in testing a potential new therapy in people. They focus on determining the right dose and method for delivering a drug. The ultimate question Phase I trials seek to answer is: Can this new drug slow down or stop cancer growth in a dose patients can tolerate?
Patients are monitored very closely to ensure their safety. As cancer research has evolved, drugs have become much less toxic, lowering patients' risk significantly, said Moshe Talpaz, M.D., associate director of translational research at the U-M Cancer Center.
"Traditionally, when we looked at chemotherapy, we looked at how much we could give a person, assuming that more is better. We know now from Gleevec and other drugs that more is not always better. Now we're looking for the optimal biologic dose and the biological changes associated with response," he said. "It probably provides a better chance of benefit than in the past because we have become more systematic in our research."
This article first appeared in the Winter, 2009 issue of Thrive. Read the magazine - opens as a .pdf document.