New Auckland clinical trials unit for cancer drugs

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Cancer patients' access to the latest treatments is being expanded at Auckland City Hospital with the creation of a new clinical trials unit.

An anonymous donation of $1.4 million has enabled the unit, a joint initiative with the University of Auckland, to be established.

It will focus on phase one clinical trials of candidate drugs including some in the same class as Keytruda and Opdivo, which have proven so successful in extending the lives of some people with advanced melanoma.

Phase one trials are the first-in-humans trials of potential drugs and typically aim to test safety and find the optimal dosage, although increasingly they also assess efficacy in specific patient groups, such as those with a known gene mutation.

There are risks for the guinea-pig patients, although these are said to be minimised in a formal clinical trials unit with proper safety protocols. But access to clinical trials can also be a life-saver for patients who have run out of options.

``We've dabbled in phase one clinical trials for years,'' said Dr Richard Sullivan, director of blood and cancer services at the Auckland District Health Board. ``We are now establishing a proper phase one programme.''

''[It] will be designed and run to the highest possible standards expected of accredited phase one units elsewhere globally.''

He said the aim in the United States was to have 20%  of cancer patients enrolled in clinical trials. Having this many enrolled helped to drive quality, safety and good outcomes for patients.

For the Regional Cancer Centre at Auckland Hospital, the aim was to have 15% to 20% enrolled in clinical trials - a big increase on the current 3%.

The new phase one trials unit will be housed in a refurbished area that previously housed the bone marrow transplant unit.

The university said the phase one trials centre would be New Zealand's first specialist cancer clinical trials research unit.

``The research unit will be managed by a team from the university ... and as one of the first major projects in their Auckland Academic Health Alliance towards setting up the integrated cancer centre.''

Cancer survivor speaks up for trials

Aucklander Dr Edward Watson (52) attributes his survival through two rounds of aggressive melanoma to being put on a clinical trial

Watson, who works as principal investigator in a clinical trials unit involved mainly with diabetes drugs, was, at age 39 diagnosed with terminal melanoma.

Working for a pharmaceutical company in Australia at the time, he left his job and returned to his native New Zealand. He learned of a phase one/two trial of tremelimumab being run in the United States. He managed to be enrolled and started receiving infusions of the drug in Los Angeles.

The drug gave him a chest rash and made him feel lethargic, but after several doses his tumours started shrinking. By the following year, they had all gone, including metastases in his bones.

He stopped taking the drug after five years, in 2009. In 2010 a new melanoma, unrelated to his earlier disease, was discovered in a lymph node under his left arm.

The Los Angeles clinic still had two vials of the drug so he resumed the therapy. After the lymph node was removed, he was told the pathologist's view was that ``the tumour cells had been smashed by the drug''.

Despite Dr Watson's success with tremelimumab, the drug had gone on to ``fail'' in a phase three trial by showing no discernible difference from standard treatment for the majority of patients.

It was the forerunner of another drug ipilimumab, which was among the early immunotherapies that began the dramatic change in the previously bleak outlook for people with metastatic melanoma, a change currently riding on Keytruda and Opdivo.

``I didn't have many options at all,'' said Dr Watson.

``I think for patients who have cancer, who do not have many options, clinical trials should be part of the paradigm of treatment. Not having easy access to them in New Zealand has been very sad.

``It's very exciting to know some oncology patients will have access to phase one clinical trials in New Zealand.''

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