Finding Hope in Science:
Phase 1 clinical trials offer options when standard treatment isn't a choice
Tarnacki's husband, Bill, was key in helping her decide to participate in the research study.

For resources to help you determine whether a
clinical trial is right for you, read our
Information Guide [PDF]
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."
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