DCA CLINICAL TRIAL ALBERTA!!!!!!!!!!!

[RandyW]

Cancer patients clamour to be part of DCA trial

But only those with malignant brain tumours will be accepted

Jodie Sinnema, edmontonjournal.com

Published: Wednesday, September 26

EDMONTON - More than 100 people with lung, breast, colon, liver and other cancers flooded the University of Alberta phone lines Wednesday morning, hoping to be part of the first clinical trial to give cancer patients an inexpensive drug that shrank tumours in rats.

But the investigative team of doctors and nurses that will be testing DCA or dichloroacetate on patients are only accepting those with malignant brain tumours including multi-forming glioblastoma, commonly called "the terminator" because of its deadliness and resistance to traditional treatments.

In fact, Health Canada approved a phase 2 trial with these patients instead of phase 1 because the patients don't have time to slowly increase drug dosages of DCA. About half of glioblastoma patients die within one year, even after surgery, chemotherapy and radiation.

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Dr. Evangelos Michelakis, co-investigator of a DCA clinical trial for brain cancer, at media conference today.

Rick MacWilliam/Edmonton Journal

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Font: ****"These patients would not survive the duration of the trial if we were to start with very low dosages," said Dr. Evangelos Michelakis, whose promising research sparked interest across the world early this year. For his clinical trial, he is looking for local newly diagnosed brain cancer patients, and those for whom regular treatments haven't worked.

Those who are at the end stage of their disease - who are bedridden and need 24-hour care - aren't eligible to join the trial.

"The important thing is if these patients live better and longer," Michelakis said of his goal. "Even if someone is stable for six months, that's a win because usually people deteriorate week by week and month by month."

Michelakis and his co-investigator in the clinical trial, Dr. Kenn Petruk, head of neurosurgery for Edmonton's Capital Health Authority, said they will be able to tell if DCA is affecting the cancer cells within one month to six weeks after they start treatment. Using a PET scan - a positron emission tomography machine that Capital Health only secured in March - they will be studying if DCA reduces the amount of glucose metabolized by cancer cells. Cancer cells love sugar.

If they can change the metabolism rate of cancer cells, the researchers hope the tumour will stop growing and might actually shrink, improving quality of life. Such shrinkage wouldn't be detectable until six months into the trial.

Michelakis said he will release data as the trial progresses. He is also working with Health Canada to see if people from across Canada might be able to participate, though he only needs 50 patients to complete the trial and can't pay for the medical costs of people from outside Alberta.

"Whether this would be a miracle drug, of course it's premature to say that. It might not work in human beings."

Michelakis said the real miracle is that

a clinical trial is proceeding without support from the pharmaceutical industry.

It usually takes millions of dollars and three years to take a drug to trial. Because DCA has already been shown to be safe in humans with heart disease and metabolic disorders, and because people across the world donated $800,000 to the cause, Michelakis was able to push his idea forward within eight months.

One girl sold home-made coasters and sent a $75 cheque to support research efforts. Peace River in northern Alberta had an auction to support DCA. A Tim Horton's donated proceeds from coffee and donut sales.

"I would call it a miracle effort that this university and the health authority is (going) through all the obstacles to make this happen," Michelakis said during a press conference. "It is possible to get a generic drug and inspire a university and the government and the health authorities to contribute to a trial so this can be tested without the industry support."

He said even if the drug doesn't ultimately work on cancer patients, this first trial is still an important breakthrough.

"Regardless of whether this is going to work or not, the message we would like to pass on is that with the help of people contributing to fundraising, and the commitment of academic institutions and not-for profit institutions, this is possible," he said. "And this has huge implications for the future of health care, I believe."

He said the DCA story may inspire other places to find ways to bring generic drugs to trial without relying on big pharmaceuticals.

Michelakis said many more clinical trials need to be done on DCA before it could be approved for clinical use. Many centres need to be involved in broad trials and DCA needs to be tested in conjunction with other drugs.

He is expecting to hear back from Health Canada any week to see if a phase 1 trial, testing DCA on a small number of people with various forms of solid tumours, is approved. That trial could proceed at the same time as the trial on brain cancer patients.

About 17,500 Canadians have brain tumours, of which 60 per cent are glioblastoma. In Edmonton, about 300 people with brain tumours are treated each year, of which about 210 have glioblastoma.

jsinnema@thejournal.canwest.com

© Edmonton Journal 2007