The University of Arkansas for Medical Sciences has received a multi-million dollar grant from the National Institutes of Health for a phase 1 clinical cancer study that could increase the effectiveness of a chemotherapy drug widely used in the treatment of breast cancer and lymphoma, among other things becomes.
Named the Phoenix Trial, the trial will also help the UAMS Winthrop P. Rockefeller Cancer Institute compete for a National Cancer Institute (NCI) award given to cancer centers across the country that focused rigorous standards for transdisciplinary, state-centered cutting-edge research focus on developing new and better approaches to preventing, diagnosing and treating cancer, “according to the NIH.
There are 71 NCI-designated cancer centers in the United States, mostly affiliated with university medical centers such as UAMS, where the Rockefeller Cancer Institute recently opened a Phase 1 clinical trial for cancer studies.
This is the center’s first Phase 1 cancer study.
Such studies are important because they are often the first time drugs are tested in humans, paving the way for phase 2/3 studies and ultimately regulatory approval.
The drugs in the Phoenix trial have already received approval from the US Food and Drug Administration.
Dr. Michael Birrer, director and vice chancellor of the Rockefeller Cancer Institute, said he also believes the NIH-sponsored $ 3.5 million study will help attract more industries to Arkansas, particularly pharmaceutical and biotechnology companies.
“This is a big step for us and a big step for the state of Arkansas,” said Birrer. “There is a real opportunity to use this for both the health of our patients and from an economic point of view.”
The study focuses on two drugs, dexrazoxane and doxorubicin, used in conjunction with chemotherapy.
Dexrazoxane is given with doxorubicin to reduce possible heart damage caused by doxorubicin, the cancer-fighting drug.
The problem was that dexrazoxane decreased doxorubicin’s effectiveness in killing cancer cells, although the drug helps prevent long-term heart damage, which is not uncommon with chemotherapy.
Over the past decade, the field of cardio-oncology has emerged to study cardiovascular diseases that occur as a side effect of chemotherapy and radiation therapy.
The field has grown in importance as cancer patients live longer and experience the negative side effects of chemotherapy on their heart more often as they age, Birrer said.
“Honestly, our patients live longer, and when they live longer, they get more of the downstream toxicity effects, including long-term damage to the heart,” said Birrer. “So this is really important.”
Because of the potential for heart damage, the two drugs are not used as often, Birrer said.
Doctors “fear that [dexrazoxane] Not only does it protect the heart, but it also prevents the drug from killing the tumor, “Birrer said.
This process could change that.
UAMS researcher Dr. Hui-Ming Chang, who leads the study, said she found through experiments with mice that dexrazoxane, given eight hours before doxorubicin, completely protects the heart without affecting doxorubicin’s ability to kill cancer cells.
Chang says her results are a major breakthrough because heart damage caused by doxorubicin, the cancer drug, is “irreversible.”
“I like this project because it’s about prevention,” said Chang. “The best way is to prevent it first [heart] Damage happens. “
That’s almost instantly with doxorubicin, she said.
Chang tells the story of one of her students whose father had childhood leukemia who was treated with doxorubicin only to develop severe heart problems by the age of 50 that required an implantable defibrillator.
“In this particular case, it was amazing to hear that story,” said Chang. “This is early for the typical population in need of this intervention.”
“That’s the delayed effect,” said Chang. “You hear cases like this. It may not come right away. For some people [heart damage] can be earlier, for some it will be later. “
Chang said tests on mice show that giving dexrazoxane eight hours before the other drug breaks down a protein that would allow doxorubicin to damage the heart.
“This protein stays broken down long enough for dexrazoxane to leave the system so that it doesn’t block the beneficial effects of doxorubicin,” she said.
The study recruited 25 healthy women aged 18 to 65 years.
If phase 1 is successful, a phase 2 study would focus on female patients with non-metastatic breast cancer because of the prevalence of breast cancer in women and the high survival rate of the disease.
“If the data is what we expected, it is indeed a wonderful thing for patients,” said Chang. “But we have to wait and do things step by step to get the data we need.”
Women who want to volunteer for the study can send an email [email protected] Compensation is possible.