Kansas clinical cancer trial groups awaiting grant news
04/09/2014 4:43 PM
08/08/2014 10:23 AM
For Marcie Kelly, it began with a suspicious-looking mole.
For years, she had been a lifeguard in high school and in college. Now it seemed the time in the sun was catching up with her.
“I went in as quickly as I could, and it was removed,” said Kelly, who works in pharmaceutical sales, is married and has three sons.
“At age 33, I never expected to be a cancer patient.”
The pathology showed it was melanoma. She had 17 lymph nodes removed, and tests showed the cancer had spread to two of them.
So she started treatments in October using the drug interferon as part of a clinical trial comparing it to a newer drug. The treatments last a year, and although the drug makes her feel as if she has the flu, she’s hopeful about the results.
Kelly is one of hundreds of local patients taking part in clinical cancer trials, which could change drastically as the Wichita Community Clinical Oncology Program faces consolidation with other federal programs under the National Cancer Institute.
“I’m doing my part to help the future of medicine for future patients,” Kelly said. “The sun is not going away. The risk of melanoma continues to grow, so being part of a study helps future patients.”
There are about 60 community clinical oncology programs nationwide, and those programs and others are competing for new federal grants that begin in September that would allow them to continue to enroll clinical cancer patients as the current clinical trial system is overhauled.
Keisha Humphries, oncology service line administrator for Via Christi who oversees operations for Wichita’s CCOP, says there have been about 115 grant applicants under the new program, but only about 50 will receive funding.
Wichita CCOP officials won’t know until May or early summer whether they’ve been awarded the funding.
If they don’t get it, the program will continue to provide clinical trials to the community but on a much smaller scale, Humphries said.
Since it started in 1983, the Wichita CCOP has had more than 15,000 patients in clinical trials. Currently, the local program has about 1,500 patients in 120 clinical trials that focus on several types of cancers at various stages.
Wichita CCOP has an annual budget of about $2.3 million, mostly from federal grants from the National Cancer Institute. That source of funding has been a mainstay of the CCOP for 30 years, Humphries said.
Funding gap concerns
In addition to waiting on the funding decision for the new program in September, Wichita CCOP officials have concerns about a potential funding gap that could affect patients and staff members.
On Friday, the American Society of Clinical Oncologists released a statement regarding their concerns about a potential gap between June 1 and the start of the new grant program in September.
“This will result in a dangerous disruption of cancer care for patients who rely on these trials,” the statement said. “To be very clear, (CCOPS) are being forced to choose between either ceasing or self-funding research activities.”
The Wichita CCOP was told by the government in March that it would receive a letter saying its current grant award would end May 31, Humphries said, but it has not yet received that letter.
A spokesman for the National Cancer Institute told The Eagle that no current patients involved in clinical trials will be affected by the changes, but he did not answer specific questions about funding for the sites over the summer.
In a recent news release, the institute stated: “Existing sites that are not successful in the competition for ... awards will receive funds needed to ensure a smooth closeout of operations. In accord with traditional NCI practice, no patients will be removed from a trial as a result of the reorganization, and accrual into existing studies will continue.”
But oncologist Shaker Dakhil, president of the Cancer Center of Kansas and principal investigator for the Wichita CCOP, said the federal institute has not yet committed to funding the programs over the summer – despite promises that patients will not be removed from trials.
He said that most patients in CCOP programs across the country will not be removed because physicians and other groups would rather pick up the cost than risk patients not receiving treatments.
“They’re banking on the fact that physicians will do it regardless, even though they’re not going to be paid,” Dakhil said.
On Feb. 17 – his 47th birthday – Kraig Moore of Mulvane was diagnosed with metastatic malignant melanoma.
He has had 33 lymph nodes removed and is undergoing immunotherapy treatment as part of a study.
“For people like me, this is happening in the dead center of treatment,” Moore said. “It’s terrifying, frankly.
“If we have this trial, and it shows promise to people in need and the continued research shows promise, why wouldn’t you continue to fund that? ... Real people fall into that gap. It’s not just a funding question,” Moore said. “There are humans in that equation.”
Wichita CCOP officials say they won’t know whether they’ve been awarded the grant for the new program that starts in September for at least another month.
If it is awarded the new grant, the Wichita CCOP will be able to accept about 400 new patients for clinical trials a year – about half of what it takes now, Humphries said.
But the CCOP would receive about twice as much in reimbursements per patient than before – about $4,000 each, she said.
Humphries said she’s hopeful the Wichita program will be picked.
“I would be shocked if we’re not selected,” Dakhil said, referencing a high patient participation in clinical trials in Wichita.
The Wichita CCOP accrues the second-highest rate of patients for clinical trials in the country among CCOP programs, Humphries said. The national average of cancer patients involved in clinical trials is 2 to 3 percent, she said, but in Wichita, it’s about 34 percent.
The Wichita program has 24 employees whose salaries are paid through the federal grants, Humphries said.
As part of the new program, the areas of cancer research would be expanded to include studies on cancer control, prevention, treatment and how cancer care is delivered in communities.
“We would be collecting additional data,” Humphries said.
The Wichita program works with such facilities as MD Anderson in Texas, Mayo Clinic in Minnesota and Johns Hopkins in Maryland so that those clinical trials are available to Kansans.
“That way our patients locally can participate and stay close to home. It’s not as hard on the family or financially, like going out of town,” Humphries said.
As part of the new grant application, the Wichita CCOP has proposed a consortium of providers throughout the state to participate in the program, Humphries said.
Providers who have signed letters of support for the partnership include Via Christi Health, Wesley Medical Center, West Wichita Family Practice, Associates in Women’s Health, oncology and radiation at Lawrence Memorial Hospital, Hutchinson Clinic, Wichita Surgical Specialists and Cancer Center of Kansas.