Monday, October 24, 2016

Clinical trial on lymphoma is suspended

Cancer researcher's work put into question by his failure to file timely report on deaths

It's no secret that new research can frequently contradict old — even when the latter has only been public for a few days or weeks.

But now comes a new wrinkle: Researchers may be invalidating their work by failing to file appropriate reports.

Or, at best, bringing their tests into question.

Case in point: An early-stage clinical trial sponsored by the National Cancer Institute on an experimental drug, ibrutinib, that involved lymphoma of the central nervous system, a blood cancer that to date had no effective treatment and was often deadly.

According to a story this week by Laurie McGinley in The Washington Post, the lead researcher failed to tell authorities in a timely manner that "two patients had died of fungal infections that might have been caused by the experimental treatment."

That failure, which led to the researcher being suspended "until he undergoes additional training," meant the trial was suspended — despite what McGinley's story called its "impressive results" in which eight of the 18 patients enrolled in the study "continue to be in complete remission, including six whose disease had not responded to previous treatment — a situation that usually causes death within a matter of months."

Dr. Francis Collins
The reporting lapses were reported by Dr. Francis Collins, National Institutes of Health director; Dr. Doug Lowe, NCI director; and other officials.

The study, which was begun in 2013, centered on ibrutinib being used in conjunction "with a cocktail of chemotherapy medications. In addition, steroids were used to reduce swelling in the patients' brains."

The principal investigator, Kieron Dunleavy, had reported concerns — after the second fatality — and "ordered CT scans in other patients in the trial to try to catch fungal infections early, before they became deadly," but he allegedly delayed filing "an official 'unanticipated problem' report" for months.

That kind of report is supposed to be filed within 24 hours of suspecting a problem caused by the treatment.

When the Federal Drug Administration — which regulates trails — learned of the problem, it "conducted a review that concluded there also were several other adverse events that weren't promptly reported," McGinley's story indicated.

Collins said "that it appeared that the combination of ibrutinib and steroids 'seemed to place patients, many of whom have compromised immune systems, at an enhanced risk of infection,'" the article said.

Information on research, and how it often flip-flops, can be found in "Rollercoaster: How a man can survive his partner's breast cancer," a book I, Woody Weingarten, aimed at male caregivers.

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