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A trial looking at if and how the drug BPA affects the body in people with a glioblastoma multiforme brain tumour (PH1/093)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

This trial is looking at a drug called Boron Phenylalanine (BPA), to find out more about how it works in the body, in people with high grade glioma. This trial is 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 that people can have safely.

A drug called Boron Phenylalanine (BPA) may help radiotherapy to kill more cancer cells. BPA builds up in brain cancer cells. It is not a cancer treatment on its own. But it can make brain cancer cells more sensitive to radiation. Because these cells will absorb more of the radiation, this may decrease any damage to the surrounding healthy cells. If trials are successful, using BPA with neutron radiation (boron neutron capture therapy) may become a treatment option in the future. But more work needs to be done to see how BPA affects the body. The aims of this trial are to

  • See how BPA affects the body, and how quickly the body can get rid of BPA
  • Find the best way (route) of giving BPA
  • Find out more about the side effects of different ways of giving BPA and how to treat them
  • Find the best dose of BPA to give

You will not have any direct benefit from taking part in this trial, and it is unlikely to change your treatment plan in any way. But the results of the trial will be used to help people with cancer in the future.

Recruitment

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

Phase

Phase 1

Who can enter

You can enter this trial if you

  • Have had a scan which suggests you may have a single brain tumour called glioblastoma multiforme
  • Have agreed to have a stereotactic biopsy to confirm your diagnosis
  • Have satisfactory blood and urine test results
  • Are well enough to take part (performance status 0, 1 or 2) (0 or 1 if you are over 65)
  • Are between 45 and 75 years old
  • Are willing to use reliable contraception for 4 weeks before you start the trial until 6 months after the trial, if there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

  • Have had radiotherapy to your head (cranial radiotherapy)
  • Will be at high risk of complications when the drug mannitol disturbs your brain’s protective filter (blood brain barrier) - a CT scan can show this and your doctor can explain if this applies to you
  • Have had uncontrolled fits in the past
  • Have had any other cancer except carcinoma in situ of the cervix or basal cell carcinoma that has been removed by surgery (resected)
  • Have had hormone therapy, immunotherapy or chemotherapy for your brain tumour in the past
  • Will be having any other trial or cancer treatment when you are due to enter this trial
  • Have a condition where your body can’t break down protein properly (‘phenylketonuria’ or PKU)
  • Have had major chest (‘thoracic’) or tummy area (abdomen) surgery in the 4 weeks before you are due to enter the trial, and have not yet recovered
  • Have an uncontrolled infection
  • Have a condition where you develop blood clots in your veins (thromboembolic disease)
  • Have had a heart attack in the last year or have heart disease that affects your daily activities, blocked arteries or a condition where your heart can’t pump blood quickly enough (congestive heart failure)
  • Have hepatitis B, hepatitis C or HIV
  • Have any other condition which would make you unwell if you took part, or affect the results of the trial - you can check this with your doctor
  • Are pregnant or breastfeeding

Trial design

This trial will recruit between 15 and 36 patients into 6 groups. Neither you nor your doctor will be able to decide which group you are in. This trial has 2 stages. Stage 1 is to find the best way to give BPA, and will have 4 groups of people.

  • Group 1 will have BPA through a drip into a vein (intravenous infusion)
  • Group 2 will have a drip (mannitol) into an artery, followed by the BPA through a drip into a vein
  • Group 3 will have BPA through a drip into an artery (intra arterial infusion)
  • Group 4 will have mannitol through a drip into an artery, followed by the BPA drip also into the artery

You have BPA over 2 hours. If you have mannitol, you have this over 30 seconds.

Stage 2 of the trial is to find out the best dose of BPA to give. You will have your BPA through a drip into a vein (IV) or an artery (IA), depending on the best results from stage 1. If the extra mannitol was successful in stage 1, you will have this too.

The first patients taking part in stage 2 (Group 5) will have a higher dose of BPA than the people in stage 1. If they don’t have any serious side effects, the next patients (Group 6) will have an even higher dose.

Whichever group and stage you are in, you will have BPA over 2 hours, just before your planned surgery to take a biopsy to confirm your type of brain tumour. 

At the start of the procedure, the staff will put one or 2 fine tubes into a vein in your arm.  One is for taking blood samples, and the other is for giving the general anaesthetic to prepare you for your planned brain biopsy.  When you have had your general anaesthetic, the surgeon will put a thin tube into a vein or artery (or both, depending on the group you are in) in your neck, for the study.  You will have the BPA and mannitol through these tubes.  Everybody will also have another thin tube put into a vein in their neck, which the team will use to take samples of blood coming from the brain.

One hour after you have had your BPA, you will have a stereotactic biopsy, in almost the same way as if you were not in the trial. For your trial biopsy you will have 2 extra holes drilled into your skull. Your surgeon will place some tiny tubes called ‘microdialysis catheters’ into your brain through these extra holes. They will use these tubes to collect samples of fluid for the trial. The risk of any complication from these extra tubes is very low.

Your surgeon will take samples (biopsies) to test for your suspected cancer, and for traces of BPA. Depending on the location of your tumour, they may also take a sample of the fluid that surrounds your brain and spinal cord (cerebrospinal fluid, or CSF).

If you are due to have surgery, you will then have your operation.

You will have some blood and urine tests while you are in hospital to see how your body handles BPA.

The doctors will remove all your tubes before you go home.

For 48 hours before your BPA and stereotactic biopsy, you must avoid food and drink containing the chemical phenylalanine, as this may affect the study results. This includes cola, chicken, nuts, cheese, eggs, steak, bananas and milk. Your trial team can give you a full list of foods to avoid.

Hospital visits

Before the trial you will see the doctor and have some tests. These tests include

You will then come to hospital to have your BPA and biopsy, with or without surgery. You will stay in hospital for 2 nights if you are not having surgery. You will stay in for at least 2 nights if you are having surgery after your biopsy. There is more information about what to expect after your brain surgery on CancerHelp UK.

One week after your biopsy, or when you finish the study, you will see your doctor. You will have further tests, including a physical examination, and blood and urine tests.

Side effects

It is possible there may be some side effects in this trial that we don’t know about yet.

In other clinical trials with BPA, patients had very few side effects related to the drug. At high doses in laboratory studies, BPA caused a small drop in blood cells. This may cause an increased risk of infection, bleeding problems, tiredness and breathlessness if given to someone, but this is unlikely. But the side effects from this trial are more likely to be from how you have these drugs, not from the drugs themselves.

If you are in a group having the extra drip (mannitol) before your BPA, the side effects may include

  • Damage to part of your brain because of lack of blood supply (stroke)
  • Fits
  • Raised pressure in your brain

These risks are all possible complications of brain tumours whether you have treatment or not. Mannitol can also cause changes in your heart rhythms. Your doctor will watch you closely for this.

There is a very small risk of bleeding and infection when you have the tiny sampling tubes (microdialysis catheters) put into your brain. Your surgeon will watch you closely for this.

Having a thin tube (catheter) put into your vein or artery can carry the risk of blood clots and infection.  The team will monitor you closely for these.

You will also be exposed to a very small amount of extra radiation in this study.  The team do not believe this will be a risk to your health.

You can find more information about brain tumours on CancerHelp UK.

Location of trial

CLOSED

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street
London
EC1V 4AD

Chief Investigator

Professor Garth Cruickshank

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

Supported by

Cancer Research UK (Drug Development Office)
Experimental Cancer Medicine Centre (ECMC)
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Updated: 11 September 2012