U-M Cancer Center’s Phase 1 clinical trials offer hope for new treatments
8:12 am in Cancer Research, Clinical Trials by admin
The ultimate goal in cancer research is to speed promising therapies from the laboratory to the clinic — where all patients may eventually benefit. That’s at the core of the University of Michigan Comprehensive Cancer Center’s Ravitz Foundation Phase I/Translational Research Center. An integral part of this this highly innovative program is that it offers new opportunities to patients who have no other treatment 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.”
The Ravitz Center is unique in that it focuses solely on targeted therapies. In this approach to cancer treatment, researchers try to develop medications that interrupt the signals that cause cancer cells to reproduce.
Because targeted therapies are focused on cancer cells specifically, they tend to cause fewer side effects.
“Unfortunately, there are diseases where there are no standard treatments,” said David Smith, M.D., clinical director of the Ravitz Center. “One of the things we can offer in that situation is a clinical trial of a promising targeted therapy. These studies don’t come with the typical side effects of standard chemotherapy — which even though that’s a more common therapy, is really a long shot for certain patients with rare or advanced disease.”
Ultimately, the goal of the Ravitz Center is to bridge the gap between the laboratory and the clinic. In Phase I trials, patients with several types of cancer may participate in a single study. Once researchers determine the best dosage of a drug, they will use what they learn to help develop broader studies.
Phase II and III trials — which study a therapy’s effectiveness and involve larger numbers of patients — are also conducted throughout the Cancer Center. The core difference is that the Ravitz Center brings some of the most promising ideas from Cancer Center labs into the clinics.
The Cancer Center is a leader in the field of cancer stem cell research. Cancer stem cells are the small number of cells within a tumor that are capable of fueling the tumor’s growth. These cells generally represent fewer than 5 percent of all cells in a tumor, but they are believed to be the cells that cause cancer to grow and spread.
Researchers believe more effective cancer treatments could be developed by finding ways to target and kill cancer stem cells. Eventually, these concepts will be tested in Phase I trials at the Ravitz Center, Talpaz said.
Regardless of which ideas the Ravitz Center is exploring through clinical trials, its doctors and staff always put patients and families first.
“We have new ways to provide our patients with access to cutting-edge treatments that we havent had before,” Smith said. “But ultimately, our fundamental goal has never changed: We’re here to take care of people. This gives us one more way to do that.”
To find out if you may be a potential candidate for a trial, talk with your physician or call the Cancer AnswerLine at 1-800-865-1125.




