Cancer clinical trials: Five myths worth busting

As a participant in a clinical trial, Mike McReynolds of Fort Worth could be one of the first patients with gliobastoma (a type of brain tumor) to benefit from a brand-new treatment.

Or not.

He could be getting a placebo. And no one’s guaranteeing the new treatment works.

But McReynolds, 69, jokingly calls his decision to join the clinical trial a “no-brainer.” Almost two years after diagnosis, he’s feeling good and working full time, and he credits the trial.

Many more cancer patients stand to benefit from clinical trials, and with hundreds of anti-cancer drugs in the pipeline, researchers could make faster progress if more volunteered. But less than 3 percent of adult cancer patients in the United States participate in clinical trials, according to the National Cancer Institute. Many doctors don’t encourage patients to volunteer, and patients fear they’ll compromise their treatment if they do.

But clinical trials for cancer don’t work the way many assume. Here are some misconceptions and some facts.

Myth No. 1: Placebo means no treatment.

Many patients are scared off from clinical trials out of fear they’ll get a placebo, says Dr. Karen L. Fink, a neuro-oncologist at Baylor Charles A. Sammons Cancer Center in Dallas.

“But placebo doesn’t mean no treatment,” she says. In most cancer-related clinical trials, “you get the best available therapy, plus you have a chance of getting a new treatment as well.”

Fink is conducting the clinical trial that McReynolds joined, testing whether a vaccine called ICT-107 will stimulate the immune system to kill tumor cells. Because it’s a randomized, double-blind study, only 2 out of 3 participants actually receive the vaccine; others get a placebo.

Neither McReynolds nor Fink knows which he’s getting, and he may never find out. But McReynolds underwent surgery and radiation before joining the trial. He’s getting the standard chemotherapy along with the investigational regimen.

“At a minimum, I’m getting the treatment I’d get anyway, and I’ve got a 2 in 3 chance of getting something that might be better,” McReynolds says.

Myth No. 2: Clinical trials are only a last-resort option.

Not true, according to Dr. Joan Schiller, deputy director of the Simmons Cancer Center at UT Southwestern Medical Center.

“We have clinical trials for people who are newly diagnosed as well as those who have exhausted all of the existing treatments,” she says. Some trials test the effectiveness of new combinations of existing treatments. Other trials, focused on prevention or detection, enlist healthy volunteers who don’t have cancer. Patients in remission can consider trials for interventions that could help prevent recurrence.

Myth No. 3: Clinical trials require travel to another city.

Not always. Nearly 70 cancer-related clinical trials are in progress at UT Southwestern in Dallas, involving thousands of patients and investigating questions ranging from the “molecular characteristics of tumor cells” to “evaluating fatigue and hope in pediatric hematopoietic stem cell transplantation recipients.”

At Baylor, a new Innovative Clinical Trials Center opened in early September, paving the way for more research. “That’s helping to attract trials of some of the newest, most exciting targeted therapies to Baylor,” says Dr. Alan Miller, head of the Sammons Cancer Center.

Myth No. 4: Clinical trials are exorbitantly expensive.

A few insurers won’t pay for any treatment associated with a clinical trial. But in most cases, the insurance company pays for the cost of standard treatment — what the patient would receive if he or she were not part of the trial — and the research institution or sponsor covers any additional costs. Bottom line: Most patients don’t pay any extra to participate in a clinical trial.

Myth No. 5: Patients are guinea pigs in clinical trials.

Actually, most patients report that clinical trials are relatively positive experiences, Fink says. Because trials require extensive documentation, participants get extra attention, and she thinks that’s why patients in clinical trials — including those who only get placebos — tend to do a bit better than those who don’t join clinical trials.

Laws regulate clinical trials to ensure patient safety as well as scientific rigor. The Food and Drug Administration must approve new drugs for investigational purposes before they’re used in clinical trials, and typically drugs or treatments are studied for years before they’re offered to human patients.

Still, it’s a good idea to discuss a clinical trial with your oncologist, who can help weigh the potential risks and benefits, advises Dr. Lalan Wilfong, an oncologist at Texas Health Resources in Dallas.

“I tell my patients to bring in the paperwork and consent forms for the trial and we’ll go over them together,” he says. “None of us is going to put a patient in a clinical trial unless we’re convinced that the patient will benefit or potentially benefit.”

Added benefits

For some patients, clinical trials offer an intangible bonus: the chance to contribute. That’s one reason Maurice Griffin, 55, of Dallas said yes to a clinical trial at Baylor for a new combination of chemotherapies called FOLFIRINOX, after he learned he had early-stage pancreatic cancer last Thanksgiving.

“I thought, ‘If somewhere down the line, if some poor schnook gets this, maybe [the study] will help,’” Griffin says. “There’s a human instinct to make something good come out of this. It’s both selfish and altruistic.”

Griffin is doing well, and that’s the hope for every patient who participates in a clinical trial, says Dr. Scott Celinski, one of the investigators at Baylor Research Institute leading the FOLFIRINOX trial.

“But even patients who don’t benefit themselves are contributing to our knowledge of the disease,” Celinski says, “and that will help other patients in the future.”

“Every single drug we use today has been through this process,” Schiller says. “Clinical trials are the only way we can make progress.”

How to find clinical trials

There are several ways to explore options for cancer-related clinical trials:

Clinicaltrials.gov is a national, searchable website of all clinical trials in the U.S. involving human subjects.

The American Cancer Society has a clinical trials matching service. Call 1-800-303-5691 or visit cancer.org. (Click on “Find Support & Treatment” and then “Clinical Trials Matching Service.”)

The National Cancer Institute has a 10-step guide to finding clinical trials at cancer.gov/clinicaltrials/search/treatment-trial-guide

UT Southwestern Medical Center has a searchable online “Find a Clinical Trial” page at utsouthwestern.edu/research/fact/index.html.

Baylor Sammons Cancer Center offers a patient navigator hotline that can assist patients looking for clinical trials. You don’t have to be a patient at Baylor. Call 214-818-8382 or 214-820-3535.

Mary Jacobs is a Plano freelance writer.