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A trial looking at a drug called BPA in people with a glioblastoma multiforme brain tumour (PH1/093)

This trial looked at a drug called Boron Phenylalanine (BPA). The people taking part had a brain tumour called high grade glioma. The trial was supported by Cancer Research UK.

Doctors usually treat fast growing, or high grade brain tumours with surgery, to remove as much of the cancer as possible. They then treat any remaining cancer with radiotherapy. But there is a limit to the amount of brain radiotherapy you can have safely.

Boron Phenylalanine (BPA) may help radiotherapy to kill more cancer cells. It is not a cancer treatment on its own but it can make brain tumour cells more sensitive to radiation. Having BPA might mean people could have a lower dose of radiotherapy, but researchers wanted to find out more about BPA.

The aims of this trial were to

  • See what happens to BPA in the body
  • Find the best way of giving BPA
  • Learn more about the side effects of BPA
  • Find the best dose of BPA to give

Recruitment

Start 04/10/2007
End 03/09/2012

Phase

Phase 1

Summary of results

The trial team found that the best way to give BPA was through a drip into an artery.

This trial recruited 10 people in total. The researchers looked at 4 different doses of BPA and different ways of giving it.

  • 3 people had BPA through a drip into a vein
  • 3 people had BPA through a drip into an artery
  • 3 people had a drug called mannitol through a drip into an artery followed by BPA through a drip into a vein
  • 1 person had mannitol through a drip into an artery followed by BPA through a drip into an artery

The researchers took a small piece of tissue (biopsy) to find out whether giving BPA through a drip into a vein or artery was better. They did this by looking at how much BPA was absorbed into the tissue. They found that giving BPA through a drip into an artery was better.

The researchers found that it took 2 to 4 hours for most of the BPA to be absorbed by the tumour. So this would be the best time to have radiotherapy.  

Only one person had a side effect that was possibly caused by BPA. That side effect was a rash which started five days after they had BPA and settled without any treatment.

When the trial was reviewed by a team of scientists, doctors and experts they found that recruitment was difficult. This was because there was a very short time between people seeing their doctor and then having surgery. Although the team tried to recruit the last 2 people, they couldn’t. So the decision was made to close the trial. This was not due to safety concerns.

We have based this summary on information from the team who ran the trial.  As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.

Chief Investigator

Professor Garth Cruickshank

This is Cancer Research UK trial number CRUKD/07/062.

Supported by

Cancer Research UK (Centre for Drug Development)
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Updated: 10 June 2014