Cancer Trial Halted After Treatment Causes Three Deaths

A cancer treatment study had to be halted by authorities after three deaths were reported to have occurred during the trial.

Juno Therapeutics was in the second phase of their cancer trial when three deaths happened as a direct result of the treatment, when mixed with a certain form of chemotherapy. The cancer treatment being studied is known as JCAR015 and is for adults suffering from relapsed, or refractory, B cell acute lymphoblastic leukemia.

CAR-T trial, as it’s called, involves taking immune cells from a cancer patient and genetically engineering them so that they can recognize and destroy cancer cells. Once the T-cells are altered, they are put back into the body.

The trial calls for cancer patients to undergo chemotherapy before the genetically altered T-cells are put back into their bodies. The chemotherapy kills off some of the cancer patient’s immune system, which allows the altered cells to work quicker and more efficiently without causing an elevated immune reaction.

Initially, the company used only one chemotherapy drug in their cancer research trial, cyclophosphamide.

Three hundred patients were part of this cancer trial, and other similar ones, that used only cyclophosphamide with the JCAR015 therapy. At that time, there were no deaths and enough success that it spurred excitement throughout scientists, doctors, authorities, cancer patients, and investors.

While using just the one chemotherapy drug, 80 percent of the adults involved in the cancer trial went into complete remission, at least temporarily. Scientists sought to raise the success rate, though.

Researchers involved in the CAR-T trial explained to the New York Times that putting the trial patients through dual chemotherapy before adding the JCAR015 therapy was much more effective, so they added another drug: fludarabine.

That’s when the cancer trial began to go wrong.

After the first death occurred, scientists weren’t sure what the reason behind it was. Both the company holding the trial and the U.S. Federal Drug Administration (FDA) said the May death had “compounding factors,” according to RT.

It was only after two more deaths occurred in the cancer trial this month that scientists became aware that the newly added chemotherapy, fludarabine, was responsible for the “severe neurotoxicity” that presented as brain swelling. The kind of swelling that occurred is known as “cerebral edema.”

“This sort of thing is incredibly common in new drug development. It’s unfortunate, but I don’t know how you avoid it,” Chief Medical Officer for the American Cancer Society, Dr. Otis Brawley, told the Associated Press.

After the third death, the FDA was forced to shut down the CAR-T trial, at least temporarily.

Stocks in the company responsible for the cancer trial fell, but so did stock in the other two companies that were also researching similar methods of cancer treatment. Investors have become nervous that the same problems could arise throughout each cancer trial working on a similar form of treatment.

However, Juno Therapeutics is not giving up.

The company has already requested that the FDA allow them to continue the cancer trial. The company has agreed to not use fludarabine and will instead use only cyclophosphamide, which was how they moved past the safety trial.

According to UPI, in response to Juno’s request, the FDA has requested “a revised patient informed consent form, a revised investigator brochure and a revised trial protocol before possibly allowing [the cancer trial] to continue enrolling patients.”

Juno has already submitted the paperwork required of it and they hope to continue the cancer trial again as soon as possible.

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