UAMS' First Phase 1 Cancer Clinical Trial Testing New Way to Protect Hearts While Treating Cancer


 

LITTLE ROCK - The drug dexrazoxane has a reputation akin to someone who both fights and sets fires.

On the one hand, this Food and Drug Administration (FDA)-approved drug prevents heart damage caused by doxorubicin, which is used in chemotherapy. On the other hand, dexrazoxane may undermine the cancer treatment, causing many doctors to leave it on the shelf.

UAMS researcher Hui-Ming Chang, M.D., MPH, 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 (NIH) 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. Cancer clinical trials at UAMS were previously limited to phase 2 and 3 studies.

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

Dexrazoxane has been on the market since 2007, and doctors traditionally administered it to cancer patients at the same time as doxorubicin. 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 eight-hour timeframe relates to dexrazoxanes' two-hour half-life, meaning it dissipates from the body within eight hours (four half-lives).

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

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.

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.

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. Almost every cancer treatment offered to patients today has come about because of a clinical trial.

 
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