Participants Needed for UAMS’ First Phase 1 Cancer Clinical Trial

Researchers are testing a new way to protect hearts while treating cancer.

Dr. Hui-Ming Chang headshot

Dexrazoxane is a drug approved by the U.S. Food and Drug Administration that prevents heart damage caused by doxorubicin, which is used in chemotherapy. However, dexrazoxane may undermine cancer treatment, causing many doctors not to use it.

University of Arkansas for Medical Sciences researcher Dr. Hui-Ming Chang believes she may have found a way for dexrazoxane to protect the heart without hampering doxorubicin’s cancer fighting ability. With the support of a five-year, $3.5 million National Institutes of Health grant, she has begun 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.  

“This is a significant milestone for UAMS and the Cancer Institute,” said Dr. Michael Birrer, 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.” 

Chang named her study the Phoenix Trial, an aspirational reference to the mythical bird that rises from the ashes. 

“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 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.”

Dexrazoxane has been on the market since 2007, and doctors traditionally administered it to cancer patients at the same time as doxorubicin, according to a press release. 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. 

“The earlier infusion of dexrazoxane degrades a protein that would otherwise allow doxorubicin to damage the heart,” Chang said. “This protein remains degraded long enough for dexrazoxane to leave the system so that it does not inhibit doxorubicin’s beneficial effects.” 

The phase 1 clinical trial aims to determine the most effective dose and timing for dexrazoxane prior to doxorubicin. The project will evaluate whether the dexrazoxane pre-treatment prevents heart damage caused by doxorubicin in breast cancer patients. Chang notes that preventing heart damage is especially important given the long-term survival of cancer patients, breast cancer patients in particular. 

“Breast cancer is very prevalent among women, and more than 90 percent will survive,” she said. “With such good survivorship, we want them to have a healthy heart, too.” 

The study is now recruiting 25 healthy women volunteers, ages 18 to 65. Researchers will also recruit 120 breast cancer patients with non-metastatic, HER2-negative breast cancer. Women interested in volunteering for the study can email [email protected] Compensation is available.