Health Care

Practice will conduct oncology trials

Phase 1 trials will work with cancer patients who are not responding to treatment.

November 27, 2015
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Future cancer treatment drugs may have roots in Grand Rapids.

The Cancer and Hematology Center of Western Michigan is partnering with San Antonio-based South Texas Accelerated Research Therapeutics, better known as START, on START Midwest.

The new entity will conduct phase 1 clinical oncology trials at the Lemmen-Holt Cancer Pavilion, 145 Michigan St. NE, where CHCWM has an office. START Midwest will have its own dedicated space adjacent to CHCWM.

Phase 1 clinical trials are conducted on a small number of patients, usually fewer than 30, to determine the safety and efficacy of a new drug or treatment. Drugs are first developed through preclinical trials conducted on lab animals and through lab studies. Phase 1 clinical trials come next, followed by phase 2 and phase 3 studies. The next step is FDA approval, which is then followed by a phase IV study.

CHCWM already conducts phase 2 and phase 3 oncology clinical trials and will continue to do so.

“Those will continue independently of the START program,” said Dr. Nehal Lakhani, director of clinical research for START Midwest.

He said with START Midwest, CHCWM patients will have access to a greater spectrum of clinical trial programs.

Lakhani and Dr. Timothy O’Rourke will lead START Midwest, which will be “fully representative of the program in San Antonio and will operate according to the same exceptional standard operating procedures and quality controls.”

START, which opened in 2007, is a well-known clinical trial organization that has grown to include five phase 1 clinical research sites around the globe. The other locations are in Madrid and Shanghai.

The organization refers to itself as the “world’s largest phase 1 medical oncology program,” and said it puts “more than 600 patients per year on phase 1 trials.” Those patients travel from all over the world to participate in clinical trials.

Lakhani said it is likely patients will travel from across the United States to participate in clinical trials at START Midwest.

Lakhani and O’Rourke were chosen to lead START Midwest because they have strong backgrounds in oncology drug development. Lakhani earned his Ph.D. in pharmaceutical sciences from the National Cancer Institute in Bethesda, Maryland, and also completed fellowship training in medical oncology there. He also worked at the U.S. Food and Drug Administration for two years prior to joining CHCWM.

O’Rourke is an oncologist with more than 30 years treating patients and enrolling them in clinical trials. Prior to coming to West Michigan in 1996, O’Rourke practiced in San Antonio and was an investigator in the drug development program that developed into START. O’Rourke’s previous relationship with START’s leadership is one of the reasons the organization decided to open START Midwest in Grand Rapids.

“With me and Dr. O’Rourke here, who have already done a lot of this work, it was a good fit, and that personal connection Dr. O’Rourke had with the folks in San Antonio,” Lakhani said.

He noted another reason is Grand Rapids can support a clinical trial program.

“You need a big enough patient population to be able to support a clinical trial program, and our practice is the largest private practice in Michigan,” he said. “We see close to 5,000 new patients every year. That gives us enough of a patient base to be able to support a program like this.”

A phase 1 clinical trial patient typically is not responding to standard cancer treatment.

According to the START website, “More than 50 percent of cancer patients can be cured with conventional treatments — that is, therapies with a proven response rate. However, there are many patients who do not respond to standard treatment and may be eligible for participation in our phase I clinical trials program.”

“The patients who would be eligible for the START Midwest program tend to be patients who have gone through at least a couple of standard chemotherapy regimens and it’s really not working,” Lakhani said. “These are patients that are late stage in their cancer.”

Lakhani said adult cancer patients are often reluctant to participate in clinical trials, something he would like to see change.

“Seventy percent of pediatric cancer patients end up on clinical trials; however, in the adult cancer population, it’s less than 5 percent,” he said. “People don’t take advantage of clinical trials and there is a lot of anxiety about being a guinea pig, so to speak.”

Lakhani said clinical trials are an important piece of advancing cancer care.

“There is a lot of room for improvement for cancer treatment. Clearly no treatment is perfect, especially chemotherapy treatments. We do have a lot of toxicity so there is room for improvement. We can improve upon the efficacy and maybe decrease toxicity. Clinical trials should be considered at every step of the way for patients,” he said.

He said success rates for new drugs are improving, which is promising.

“There are lots of drugs being developed by the pharmaceutical companies,” he said. “A small fraction of those will make it to FDA approval, but we try to identify the most promising drugs up front, before bringing them into our clinic.

“The science is evolving so fast that the drugs being brought into clinic now, compared to five to 10 years ago, have a much more likelihood to succeed in clinic because we are making tremendous progress in identifying the driver mutations, we understand tumor biology and genomics a whole lot better and there is exciting work going on in immunotherapy. It’s completely changed the way we treat cancer.”

Lakhani said another roadblock for adult cancer patients participating in a phase 1 clinical trial is they are often conducted at academic medical centers.

“Ninety percent of adult cancer patients will get their treatment in a community setting, which usually lacks those kinds of resources to have clinical trials,” he said.

For people who are skeptical of being a “guinea pig,” Lakhani pointed out former President Jimmy Carter was recently treated with an FDA-approved drug developed through a START phase 1 clinical trial. The drug, Keytruda, an immunotherapy agent that uses the body’s immune system to fight the cancer, is now being used to treat metastatic melanoma as part of the standard of care.

“It’s a game changer in metastatic melanoma,” Lakhani said. “Metastatic melanoma is skin cancer that has spread to distant organs and is what we call stage four skin cancer. Five years ago the life expectancy for patients with this particular disease was about nine months.

“There have been multiple drugs approved over the last five years in that particular disease. Now it’s not uncommon for patients to be in my clinic for five years from diagnosis and still be doing fine, without any evidence of disease. The natural history of the disease has completely changed. That is because of several new drugs that have been approved.”

He said the list of FDA-approved drugs START has been involved with “reads like a who’s who of phenomenal drugs we’ve had in cancer.”

According to START, its researchers can claim a “direct, hands-on involvement with the clinical development of more than 19 anticancer drugs that, in the past 18 years, have obtained FDA approval and are now considered a part of standard of care.”

But, Lakhani noted, “In order to get a drug of the future, you have to participate in clinical trials today, because the drug approval process takes several years. If you are running out of standard treatments that aren’t working for you, clinical trial might be the best way forward.”

Lakhani said START Midwest will open in December and he expects to see patient participation grow to rival that of San Antonio’s phase 1 trials.

“The San Antonio program, which is supported by a physician practice that is our size, sees about 400 cancer patients a year, and that makes them the largest program in the United States,” he said.

Dennis Zoet, senior director of business development and operations at CHCWM, said pharmaceutical companies are already expressing an interest in working with START Midwest, with Novartis set to meet with the organization in January.

“I think the attractive thing for the pharmaceutical companies is they’ve been coming to the Van Andel Institute for many years for the preclinical trials,” he said. “Novartis is coming back to meet with us in January and they are excited because now, when they come to Grand Rapids, they not only have the lab work side, now they have the patient side. It’s a much more attractive community for them.”

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