A trial looking at Trabedersen (AP12009) for anaplastic astrocytoma that has come back after treatment or continued to grow during treatment (SAPPHIRE) - Recruitment Ends 30/06/2011
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A trial looking at Trabedersen (AP12009) for anaplastic astrocytoma that has come back after treatment or continued to grow during treatment (SAPPHIRE) - Recruitment Ends 30/06/2011

  • Saturday, 22 January 2011 06:15
  • Last Updated Saturday, 22 January 2011 06:25

This is a trial looking at a new drug called Trabedersen (AP12009) for people with a type of Brain Tumour called an anaplastic astrocytoma that has come back (relapsed) after treatment or continued to grow during treatment (is ‘refractory’). Astrocytoma means the Cancer developed from brain cells called astrocytes. Anaplastic means that the cells are very unlike normal astrocytes.

Doctors often treat anaplastic astrocytoma with surgery and Radiotherapy. If it comes back, or continues to grow, they don’t have many other treatments to use. Carmustine (BCNU) and Temozolomide are 2 types of Chemotherapy that doctors may use. Researchers think that a new drug called Trabedersen (AP12009) may be just as good as or better than carmustine or temozolomide to treat these brain tumours.

Trabedersen is a new type of biological therapy. It works by decreasing the amount of a chemical that cancer cells make.

The chemical is called transforming growth factor beta 2. It is a natural body chemical that helps cells to grow. We know from research that some cancer cells make more of transforming growth factor beta 2 than normal cells do. This can help cancer cells to hide from the body’s Immune System, making it hard for the immune system to find the cancer cells and kill them. We also know from research that the tumour can use transforming growth factor beta 2 to grow its own blood supply to provide it with the oxygen and food it needs to grow.

The aims of this trial are to find out

  • How Trabedersen compares with temozolomide and carmustine as a treatment for anaplastic astrocytoma

  • How safe Trabedersen is

  • How Trabedersen affects Quality of life

Recruitment

Start 09/12/2009

End 30/06/2011

Phase

Phase 3

Who can enter

You can enter this trial if

  • You have a type of brain tumour called anaplastic astrocytoma

  • Your tumour has came back (relapsed) or continued to grow (is ‘refractory’) after surgery and radiotherapy

  • You have satisfactory blood test results

  • You are able to take care of yourself (Karnofsky performance status 70 to 100)

  • You are willing to use reliable contraception if there is a chance that you, or your partner, could become pregnant

  • You are between 18 and 70 years old

You cannot enter this trial if you

  • Have a tumour that is in a part of your brain called the Brain Stem or hindbrain (your doctor can advise about this)

  • Have had more than 1 course of treatment with chemotherapy (your doctor can advise about this)

  • Have had another cancer in the last 5 years, except carcinoma in situ of the cervix or basal cell skin cancer

  • Have fits (seizures) that are poorly controlled

  • Have had a heart attack in the last 6 months or another serious heart condition that is poorly controlled

  • Are HIV, hepatitis B or hepatitis C positive

  • Have any type of infection

  • Have another medical condition that could affect you taking part in this trial

  • Are pregnant or breastfeeding

Trial design

This is a phase 3 international trial. It will recruit about 132 people from several countries around the world. It is a randomised trial. The people taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor can decide which group you are in.

People in group 1 will have Trabedersen. Trabedersen is a liquid. You have it straight to your brain tumour using a special system. This system is a small portable pump with a line attached.

The pump contains a small bag (reservoir) of Trabedersen. It has a line with a needle attached. The needle goes into a small port under the skin of your chest. From the port another line continues under the skin up your chest and neck, behind your ear and along your skull to where your brain tumour is. A surgeon will make a very small hole in your skull and place the tip of the line just inside, straight into your brain tumour.

Diagram showing how you have the drugs in the SAPPHIRE trial

You will have surgery, under a general anaesthetic, to place the port and line under your skin.

After surgery you will have a chest X-ray and brain MRI scan to make sure the port and line are in the correct place before your treatment starts.

The pump will give a controlled amount of Trabedersen to your brain tumour over 7 days. After 7 days the pump, needle and outside line are changed. You have a salt water solution (saline) attached for 7 days, to keep the line to your brain tumour open and free from blocking. You only need to go to hospital once every 7 days to have the pump, outside line and needle changed. Each 14 days is called a cycle of treatment. You can have up to 11 cycles of treatment (21 weeks).

After your course of treatment is finished you have surgery, under a general anaesthetic, to remove the port and line.

People in group 2 will have either carmustine (BCNU) or temozolomide. Your doctor will decide which one is the best for you.

Temozolomide is a chemotherapy capsule. You take it for 5 days, and then have 23 days of no temozolomide. Each 28 days is a cycle of treatment. You take it on an empty stomach (for example, 1 hour before meals or 2 hours after meals). You can have temozolomide for up to 26 cycles of treatment (2 years).

Carmustine is a liquid. You have it through a drip into a vein. The treatment takes about 1 to 2 hours. You have it on day 1 and no treatment for 41 days. Each 42 days is a cycle of treatment. You can have up to 8 cycles of treatment (48 weeks).

Hospital visits

You will see the doctor and have some tests before taking part in this trial. These tests include

  • Physical examination

  • Heart trace (ECG)

  • Breathing test (lung function test)

  • MRI scan of the brain

  • Blood tests

  • Pregnancy test (if appropriate)

The blood tests will include testing for HIV, hepatitis B and hepatitis C. If your blood test shows positive for one of these, the medical team will arrange for you to see a specialist to talk about it.

During treatment you see the doctor every week for blood tests. Every 4 weeks you have a physical examination and a pregnancy test (if appropriate). Every 8 weeks you have a MRI scan of the brain. You also have a urine test and heart trace (ECG).

If you are having carmustine you will have a breathing test (lung function test) every 12 weeks.

At 14 months you see the doctor and have a physical examination and MRI scan.

At the end of treatment you have a physical examination and MRI scan. If you have stopped treatment because your cancer has continued to grow you will also have a heart trace (ECG) and blood test.

After treatment people who had Trabedersen will have the pump and line taken out within 7 days.

After treatment, you see the doctor every 8 weeks for 18 months and then every 3 months until your tumour starts to grow again.

If your tumour continues to grow during treatment, your doctor may stop your treatment. You then see the doctor every 3 months.

Side effects

In earlier clinical trials this drug often caused an increase of pressure in the head ( Intracranial Pressure) that can cause an increase risk of headaches, drowsiness, fits (seizures) or a loss of movement in the body ( Paralysis).

There are possible side effects of having the line in place to give Trabedersen. They can include

  • Pain and swelling at the needle site

  • Infection

  • The line being blocked or changing position (the medical team can help with this)

The most common side effects of temozolomide and carmustine are

  • A drop in blood cells causing an increased risk of infection, bruising and bleeding problems

  • Loss of appetite

  • Feeling, or being, sick

  • Tiredness

  • Diarrhoea

  • Constipation

  • Headache

There are possible risks to having surgery to place the line for Trabedersen. Your doctor will discuss these with you.

Location of trial

  • Birmingham

  • Edinburgh

  • London

For more information

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

Tel: 0808 800 4040
Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Chief Investigator

Dr Paul Mulholland

Supported by

Antisense Pharma

National Cancer Research Network (NCRN)

 


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