A promising idea that seemed simple to implement took years, complex approval layers, and people saying, “Yes,” again and again to become a trial.
A dental wipe could one day become a life-saving standard of care for children undergoing treatment for one of the most common types of childhood cancer.
But before a seemingly straightforward intervention like this can become standard care, its effectiveness must be proven. That process is complex; it requires years of study design, careful oversight, regulatory approvals, and the right funding.
Only then can the study begin. If any one piece doesn’t align along the way, a study may never come to fruition.
In the case of Children’s Oncology Group’s (COG) clinical trial ACCL2531, the most critical element was aligning the funding, manufacturing, and distribution of the wipes themselves.
AML’s Hidden Threat
Children and adolescents undergoing intensive chemotherapy for cancer spend long periods immunocompromised, allowing the normally harmless bacteria living in their bodies to grow out of control.
For children with Acute Myeloid Leukemia (AML), one of the most significant risks comes from a group of oral streptococcal bacteria. Once those bacteria enter the bloodstream, they can lead to sepsis, intensive care admissions, treatment delays, and even death.
Dr. Adam Esbenshade, a pediatric hematologist-oncologist at Monroe Carell Jr. Children’s Hospital at Vanderbilt and Chair of COG’s Cancer Control and Supportive Care Committee, shared, “While cancer therapies are getting better and pushing the survival rate in a positive direction, these infections drive those rates down and cause patients suffering.”
While antibiotics are sometimes given preventively, they risk causing antibiotic resistance and disruption of the body’s normal bacteria. Targeting infections at the source and limiting antibiotics that affect the entire body could reduce not only infections but also the treatment delays they cause.
The Beginning of COG ACCL2531
Several years ago, Dr. Esbenshade heard that a colleague conducting transplants in pediatric cancer patients had noticed that patients using xylitol dental wipes appeared less likely to develop bloodstream infections caused by oral streptococcal bacteria.
These early, promising observations became the foundation for COG ACCL2531. This clinical trial will test whether xylitol dental wipes can effectively prevent bloodstream infections in pediatric AML patients.
“This is localized, simple, and focused on a specific problem,” said Dr. Esbenshade, who provides clinical oversight of the trial.
Dr. Esbenshade explained that xylitol is a sugar alcohol that oral streptococcal bacteria cannot metabolize the way they do glucose, leading the bacteria to die. “If this works, it could save a lot of lives,” he said.
But promising ideas alone aren’t enough. Patients and families facing pediatric cancer treatment have enough to shoulder already, balancing treatment with work schedules, family, travel, and the emotional burden of a situation no one asked for. Researchers needed to know whether the intervention truly worked before asking families to add one more step to an already demanding treatment regimen.
“If there’s something we could potentially have to help families that is a low-cost intervention, we want to figure out what it is. At the same time, we don’t want people doing something if it isn’t actually helpful,” said Dr. Wilkes, leukemia attending at Seattle Children’s Hospital and Associate Professor of Pediatrics at the University of Washington. Dr. Wilkes serves as COG ACCL2531’s co-chair and co-Principal Investigator, along with Dr. Esbenshade.
Straightforward Solution. Complex Coordination.
At first glance, using xylitol dental wipes to prevent oral infections and save lives sounds like a simple, inexpensive solution to a big challenge. But the science behind COG ACCL2531 wasn’t the biggest hurdle.
“We needed a control wipe because we had to determine whether it was the xylitol itself or simply the act of cleaning the teeth that might make the difference,” Dr. Wilkes explained.
The greatest challenge was operations.
“The challenge wasn’t just paying for the xylitol wipes. It was manufacturing the placebo wipes, as well, and distributing them to more than 100 sites,” said Dr. Esbenshade.
Vendors changed. Timelines shifted. Products had expiration dates that had to align with study activation and enrollment.
“Even after final approval, we still couldn’t get the actual wipes made,” said Dr. Esbenshade.
After years of scientific planning and regulatory approvals, the study still couldn’t begin until every operational piece was in place.
The challenge wasn’t only the cost of the wipes themselves, which was relatively modest compared with many clinical trials. It was funding the manufacturing and distribution needed before the study could ever begin enrolling patients. While participating institutions receive federal reimbursements per patient after enrollment begins, upfront operational costs—including the wipes being tested—fell outside the existing funding structure.
The Key that Unlocked COG ACCL2531
“Studies like these don’t get off the ground if the intervention isn’t funded.” – Joe McDonough
Joe McDonough, founder of The Andrew McDonough B+ Foundation, has spent nearly two decades helping accelerate childhood cancer research. In his view, philanthropy plays a unique role by supporting promising ideas early, allowing investigators to focus on science while generating the evidence needed to move discoveries through the research pipeline.
“Our role as charities is to fund the early work. Researchers can then take that to the government and eventually to the private sector. That’s how the ecosystem works,” Joe shared.
For Joe, that belief began with his son, Andrew, who was an exceptional student and athlete. “He helped his team win a Pennsylvania State soccer championship on Saturday, and on Monday they discovered Acute Myeloid Leukemia,” said Joe. “He was in the PICU for 167 days. He never left.”
Following Andrew’s death, Joe and his family established The Andrew McDonough B+ Foundation to support families facing childhood cancer while helping promising research reach children faster. B+—Be Positive—was Andrew’s blood type and the way he lived.
When Joe learned about the funding gap for the wipes, he immediately offered to donate—support Dr. Esbenshade credits with allowing the study to move forward. “Joe’s funding literally made this trial possible,” Dr. Esbenshade said. “It may not have otherwise made it to the finish line.”
For Joe, the significance wasn’t the size of the investment. It was removing one obstacle standing between an important research question and the children who could benefit from the answer. “This isn’t a million-dollar study. Sometimes the thing holding a study back seems small or trivial, but it’s exactly what’s needed to move it forward,” he explained.
While COG ACCL2531 required a relatively modest investment, the challenge it illustrates is much broader. Many important research questions, particularly those focused on improving supportive care and quality of life, don’t fit neatly within traditional funding models.
“This particular study is a little unusual because it’s relatively low cost. But many studies have important aims that benefit not only the patients in front of us today, but also the future of care. Philanthropy can help answer important questions, especially in the current funding environment,” Dr. Wilkes shared.
Without philanthropic support, Joe believes trials like COG ACCL2531 might reach patients eventually, but that’s too late for him. “Would this project have happened if I didn’t raise my hand? Not now. Maybe in a few years. But we can’t wait. Children are suffering right now,” he said.
Bigger Than One Study
For Drs. Esbenshade and Wilkes, COG ACCL2531 has always been about more than studying dental wipes.
Every bloodstream infection prevented could mean one fewer intensive care admission, fewer treatment delays, fewer complications, and a safer treatment journey for children already facing one of pediatric oncology’s most aggressive therapies.
That goal is what keeps researchers moving through years of planning, approvals, manufacturing challenges, and coordination. “We care about the patients. We care about their outcomes,” Dr. Esbenshade shared. “I hate that you can cure someone from their disease, and then they die from an infection.”
For Joe, those words carry a deeply personal meaning.
“I can’t help but wonder if Andrew ‘only’ had to fight childhood leukemia and not the infection, would he be alive today? Obviously, I’ll never know. But we want to reduce the burden on these children as they fight cancer.”
That hope continues to drive his support of studies like COG ACCL2531. “One of the things we can do is make the journey of a child with cancer easier. Fighting infection is one way to do that.”
Time Isn’t Measured in Years
Today, The Andrew McDonough B+ Foundation is the largest provider of direct financial assistance to families facing pediatric cancer in the United States. But Joe believes philanthropy’s role extends beyond supporting families to helping researchers answer questions that improve care for future patients.
He hopes COG ACCL2531 encourages other philanthropic organizations, regardless of size, to see themselves as partners in advancing pediatric cancer research. “I don’t want a charity that raises $50,000 a year to think they can’t be a partner with COG and change the world,” Joe said.
Joe sees COG as the place where philanthropy and science come together. He encourages organizations of every size to engage with COG, learn about the research underway, and discover where even modest support can help move important studies forward.
“COG is the undisputed expert and clearinghouse for the best childhood cancer research being done. Don’t be intimidated to reach out to them,” said Joe.
Advancing childhood cancer research takes more than researchers alone. It takes physicians, researchers, patients and families, public partners, and philanthropies, each saying, “Yes,” to helping promising ideas reach children faster.
“I don’t think in years,” Joe said. “I think in children.”
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