Munich

A Swiss clinical trial of a vaccine against skin cancer has been scrapped after a government-backed investigation found “serious shortcomings” in its conduct.

The inquiry, which released its results on 28 November, says that the study's methods and medical examinations were insufficiently documented, its protocols inadequate, and that several patients were treated without prior written consent.

But Frank Nestle, the dermatologist at the University of Zurich who led the study, will not face sanctions because the Swiss federal health office's inquiry found that no scientific data had been manipulated and that patients had not been put at risk.

In 1998, Nestle reported tumour regressions in 5 out of 16 melanoma patients vaccinated with a fusion of dendritic cells from the immune system and tumour cells (F. O. Nestle et al. Nature Med. 4, 328–332; 1998). This success rate dropped substantially after more patients were included in the study.

But, according to the inquiry, only the earlier, more promising results were displayed on the clinic's website. This was the case until February, when the University of Zurich responded to complaints and set up an internal investigation of the study. The clinical trial was suspended on 17 April, and the Swiss federal health office commissioned its inquiry.

The Internet material was meant primarily for physicians, Nestle says. But he admits that he cannot exclude the possibility that new patients — including some non-Swiss nationals who were charged an average of SFr9,000 (US$7,000) to take part in the study — could have been persuaded to participate because of the information on display.

Nestle says that he did not intend the website to be an advert for the study. “As an important cancer centre, we were allocated more than enough patients,” he says. In addition, he notes that treatment costs were administered by the university's hospital management, which did not break existing guidelines. “There was, of course, no personal gain,” he adds.

The initial Zurich work led to a larger, multicentre study of dendritic cells as a treatment for skin cancer, coordinated by the German Cancer Research Center in Heidelberg. Despite doubts about cancer vaccines now raised by the Zurich study, trials in Germany and Switzerland on more than 100 patients will continue.