University of Arkansas for Medical Sciences researcher Dr. Hui-Ming Chang has been awarded a five-year, $3.5 million National Institutes of Health grant to study how the drug dexrazoxane could protect the heart without hampering its cancer fighting ability.
The grant has enabled her to begin testing her laboratory findings at the newly opened UAMS Winthrop P. Rockefeller Cancer Institute Phase 1 Cancer Clinical Trial Unit. Her study is the first phase 1 cancer clinical trial at UAMS and in the state. Cancer clinical trials at UAMS were previously limited to phase 2 and 3 studies.
Dexrazoxane is an FDA-approved drug that prevents heart damage caused by doxorubicin, which is used in chemotherapy. But it has also been known to undermine the cancer treatment, causing many doctors to leave it on the shelf, according to a UAMS press release.
Chang named her study the Phoenix Trial, an aspirational reference to the mythical bird that rises from the ashes.
“This is a significant milestone for UAMS and the Cancer Institute,” said Michael Birrer, M.D., Ph.D., the institute’s director and vice chancellor. “We are especially excited to kick off our phase 1 trials with Dr. Chang’s bench-to-bedside research. As a result of her remarkable laboratory findings, there is a real opportunity to protect the hearts of patients while treating their cancer.”
Dexrazoxane has been on the market since 2007, and doctors traditionally administered it to cancer patients at the same time as doxorubicin, according to UAMS. In the lab, Chang discovered that if she gives dexrazoxane to mice eight hours before doxorubicin, it completely protects the heart from doxorubicin’s side effects and does not interfere with doxorubicin’s ability to kill cancer cells.
“Very few cancer doctors are treating their patients with dexrazoxane, but I am cautiously optimistic we can bring it back,” said Chang, a professor in the UAMS College of Medicine departments of Pharmacology/Toxicology and Internal Medicine. “If the trial successfully translates our lab findings to humans, it will revive dexrazoxane for greater use in cancer patients treated with doxorubicin.”
The study is now recruiting 25 healthy women volunteers, ages 18-65. It will also recruit 120 breast cancer patients with non-metastatic, HER2-negative breast cancer. Women interested in volunteering for the study can email PHOENIX1@uams.edu. Compensation is available.
“If the phase 1 trial is successful, we will move to the Phoenix 2 Trial for breast cancer patients. We can also involve other types of cancers, including sarcoma and pediatric leukemia, later,” Chang said.
The Phase 1 Cancer Clinical Trial Unit is part of the Cancer Institute’s state-of-the-art infusion center that opened in November 2020. Chang arrived at UAMS the same month, bringing the new Phoenix Trial with her from the University of Missouri School of Medicine. Phase 1 clinical trials are the first to involve human participants. UAMS officials said most every cancer treatment offered to patients today came about because of a clinical trial.