Radiation is a high-risk, but also a high-reward cancer therapy used to treat about half of all cancer patients.
To minimize some of the risks, a local biology professor has teamed up with a doctor at the Lacks Cancer Center in Grand Rapids to test an assay that predicts how much exposure to radiation a patient can tolerate. If the clinical trials at the center prove successful, radiation oncologists may have a new tool to guide them in determining a more precise therapy that ultimately can extend the lives of cancer patients.
It's a result that would truly please Nigel Crompton, 51, a professor of biology at Cornerstone University who has spent the last decade developing an assay that indicates a person's sensitivity to radiation therapy. Crompton sees his work as "about making discoveries...gaining understanding. It's rewarding to find ways to help people."
Expanding range and performance of choices
Radiation is considered effective against early stage cancers and types of cancer that can be isolated. The National Cancer Center reports about half of all people with cancer are treated with radiation therapy, which can delivered either by a machine externally or by an implant containing a radioactive substance inserted in the patient's body.
Being able to distinguish between patients who are particularly sensitive or tolerant to radiation treatment would give clinicians a significant advantage in setting up a treatment plan. But there has been no timely predictive procedure that provided this information.
Crompton's assay does. His test produces a result within 48 hours, giving clinical radiation oncologists the information they need to define the best possible therapy for each patient. In some cases a more aggressive treatment can be successfully employed, shortening the number of dosages needed and increasing chances for full recovery.
Clinical trials for the assay are being conducted in Grand Rapids under the direction of Dr. Gilbert Padula, a radiation oncologist at the Lacks Cancer Center, funded by a $10,000 grant from the St. Mary's Doran Foundation. The trials will validate the assay but it will take money, time, and U.S. Food and Drug Administration (FDA) approval to commercialize it.
But much of the groundwork for the assay has been completed in Europe — it is, in fact, being established in clinical labs in Switzerland, France, South Africa, and the Czech Republic.
Grand Rapids by way of Lancashire
For Crompton, it is just one more step in a journey that began far from Grand Rapids. He hails from the United Kingdom — by way of Southport, Lancashire — a shout away from the Beatles' Liverpool neighborhood and right next door to the home of stop motion animation stars Wallace and Gromit.
His boyhood interests centered on science. He had an early fascination with chemistry and physics, particularly the problem-solving aspects of the disciplines. This stayed with him throughout his studies and was cemented in his early college years. He was studying genetics and cell biology when a chance visit convinced him he was on the right course.
"One of my mates in college invited me to London for the weekend with his family," Crompton recalls. "His dad was chief medical officer of Mount Vernon Hospital. I toured the facility and we got to talking about the oncology lab."
Crompton later went to work for the hospital's Gray Cancer Laboratory and began the research that would lead to his ideas about a predictive assay for radiation candidates.
Saving time, changing lives
At the time, radiation therapy regimens were based on what was referenced as a "the 5% rule," a number that represented the percentage of patients who typically suffered intolerable late effects from radiation.
In attempt to counter these possibilities, the 5% rule is applied to radiation dosage recommendations based on clinical history averages, and not on an individual's predisposition to treatment. But rather than identify those who were at greater risk from treatment, the rule simply lessened the dosage for everyone.
Crompton and his colleagues determined that a test was necessary — a test that was reproducible, that gave a quick result, and that was cost effective. Existing options, of which there were few, required up to four weeks to perform.
In Crompton's test, the treatment center draws less than a teaspoon of blood from the prospective patient. Using a biological process, the blood sample is exposed to a form of radiation that measures its reaction to radiation toxicity. This early research indicated that such a test would work — it was easy to prepare and produce and results were available within two days.
The assay also obviated the need to rely on the 5% rule. "Our assay shows the 5 percent, who could not tolerate radiation," Crompton says. "And it shows that patients with a higher resistance rate can tolerate a higher dosage, which can have an impact on survival rates."
Settling in West Michigan
His work won Crompton attention in the United States as well as Europe, and it let him pave a career path for him to Cornerstone University, an inter-denominational, Christ-centered university founded in 1941 as the Baptist Bible Institute of Grand Rapids. The university has a total enrollment of more than 2,600 students.
"I was giving a talk at Cedarville (Ohio) University — a sister college of Cornerstone University — and I was fascinated by the faith-based atmosphere," Crompton says.
Cornerstone's emphasis is unlike other universities in Europe, Crompton says, and further investigation convinced him its principles were a good fit for him. He joined the faculty about eight years ago and now teaches introductory courses to biological sciences, origins, and molecular and cellular biology, where he has earned a reputation as a tough, but helpful instructor.
From Lacks Center trials to market ready
Along with teaching, Crompton continues to promote the assay and follow the clinical trials conducted by Dr. Padula.
Padula reports the trials have gone well and that the pair expect to soon write a paper for the Journal of Clinical Oncology, the official journal of the American Society of Clinical Oncology. While the paper will provide oncology clinicians with an explanation of the assay and its implementation, the commercial venture will have to wait.
"Everything is in place," Crompton says. "We are ready to work with radiation oncologists within FDA guidelines. But we need venture capital to set up the labs."
Medical products — from drugs to devices to processes —face rigorous review from government agencies, principally the FDA. A new drug can take several years to pass muster and may require up to a billion dollars or more for development and testing.
While Crompton's assay does not involve the validation required for a drug trial, he still sees an outlay of several hundred thousand dollars as necessary to reach commercial approval.
"A lot of it depends on the FDA officer," he suggests, yet he isn't expecting immediate results. "I've been working on this for 10 years," he says. "I wouldn't be at all surprised if it took another 5 years."
The search for funding support for FDA trial is in its early stages. Crompton indicates there is some interest in the West Michigan investment community, but no firm underwriting source has committed. He suggests the completion of a successful trial at the Lacks Center will help.
In the meantime, Crompton continues to teach. And acclimate to his new home country. While he enjoys Cornerstone's atmosphere and Michigan summers, he is not yet ready to change his sports allegiances. His favorite football -- as in soccer -- team remains Manchester United, and he will be plugging for England when it takes on the United States in the first World Cup game for both countries on Saturday. But he is generous with his wishes after the game with England. "I would be very happy for the U.S. if it does well" after Saturday's match, he says.
G.F. Korreck is a free-lance writer, editor, and voice talent living in West Michigan.
Photos:
Dr. Nigel Crompton (4)
Photographs by Brian Kelly -All Rights Reserved