SUMMIT, NJ — Overlook Medical Center in Summit is one of only four locations in the United States to begin a unique clinical trial to treat an aggressive form of brain cancer.
Glioblastoma is a central nervous system tumor that forms on the supportive tissues of the brain, and the Gerald J. Glasser Brain Tumor Center at Overlook will be starting a Phase III clinical trial of VAL-083, a new drug that aims to treat fast-growing brain tumors.
Other sites rolling out the study include: Kaiser Permanente Los Angeles Medical Center; University of California San Francisco Medical Center; and DENT Neurosciences Research Center in Amherst, N.Y.
According to the National Foundation for Cancer Research, glioblastoma is the deadliest form of brain cancer. It is widely regarded as incurable and universally fatal, killing 95 percent of patients within five years of diagnosis. Massachusetts Sen. Ted Kennedy died from the disease in 2009, and last year Arizona Sen. John McCain announced he had been diagnosed with it.
With no established cure, clinical trials persist, and patients will soon journey to Summit to receive it.
“People will travel far for treatment in my experience, particularly for treatment on a clinical trial in a situation where there is little else available in terms of treatment,” Dr. Kurt Jaeckle, co-director of the Gerald J. Glasser Brain Tumor Center, told LocalSource in a recent email. “It is an advantage that Newark airport is close by, but we expect most of the patients will come from driving distances.”
The experimental drug primarily works by, “cross-linking the tumor DNA, but also is known to inhibit DNA, RNA and protein synthesis,” Jaeckle said.
What makes the drug novel is its “capacity to penetrate the cerebrospinal fluid and brain tumor, which has traditionally been a problem for most drugs,” he said.
According to Jessica Ritter, an oncology nurse at New York Presbyterian Hospital, most drugs are unable to permeate the blood-brain barrier because of its selective properties.
The new study is now available for patients due to successful results of previous trials, prompting the drug’s developer, DelMar Pharmaceuticals of Vancouver, Canada, to put the drug out for trial.
“I think (DelMar’s) line of thought is that, prior to other treatments, they have had very little beneficial effect on patients with tumors that progress following bevacizumab,” Jaeckle said, referring to the medication commonly used to treat recurrent glioblastoma that is approved by the U.S. Food and Drug Administration.
Drugs used in clinical trials go through long approval system protocols before they can be reviewed and approved by the FDA.
“In general for most trials, the study has to reach full accrual and be a positive trial based on the predetermined decision rules, then the study data has to be reviewed by FDA, and the data has to lead (the FDA) to determine that the risk outweighs the benefit enough to warrant approval,” Jaeckle said.
According to Jaeckle, the latest clinical study fills a gap for patients still battling glioblastoma after their initial treatment.
“There are not many FDA-approved therapies specifically for post-bevacizumab patients,” Jaeckle said. “Additionally, there are very few clinical trials in the U.S. for post-bevacizumab patients.”
So far, no patients have registered for the study yet, but Jaeckle expects registration to take place soon.
“We have prescreened about a dozen patients so far; one consented to the trial but decided to stay locally out of state for treatment,” he said. “So we are still waiting to enroll the first patient, but anticipate that in the near future.”