A trial of ABT-414 for children with a glioblastoma (INTELLANCE 2 sub study)

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

Cancer type:

Brain (and spinal cord) tumours
Children's cancers

Status:

Closed

Phase:

Phase 2

This trial is for children and young people with a type of brain tumour called a high grade glioma. It is open to children and young people whose glioma has a larger number of receptors Open a glossary item for the protein called epidermal growth factor (EGF Open a glossary item).

This trial is for children and young people under the age of 18. We use the term 'you' in this summary, but if you are a parent, we are referring to your child.

More about this trial

INTELLANCE 2 was a trial of ABT-414 for adults with glioblastoma. This is a sub study of INTELLANCE 2 looking at ABT-414 for children and young people with glioma.

ABT-414 is a type of drug called an antibody drug conjugate (ADC). There are 2 parts to an ADC. The first part targets cancer cells by attaching to a particular receptor on the surface of the cancer cell. The second part is a toxin that goes into the cancer cell and kills it.

ABT-414 attaches to the epidermal growth factor receptors (EGFR) on cancer cells.

The aims of the sub study are to find:

  • how safe it is to use ABT-414 for children and young people with high grade glioma
  • what happens to ABT-414 in the body
  • how well ABT-414 works for children and young people with high grade glioma

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to join this trial if all of the following apply.

  • You have a high grade glioma Open a glossary item  
  • Your glioma has come back after, or continued to grow during, treatment or if newly diagnosed you must have finished radiotherapy at least 4 weeks before starting treatment in this trial
  • Your glioma has a large number of receptors called epidermal growth factor (EGF Open a glossary item)
  • You have recovered from any previous treatment
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if you are sexually active
  • You are not yet 18 years old

You cannot join this trial if any of these apply.

  • You have had radiotherapy with a dose of more than 65 Gray Open a glossary item (Gy) to the brain, stereotactic radiosurgery or brachytherapy Open a glossary item for a recurrent brain tumour unless samples of the tumour were tested to prove that it had come back
  • You are taking, or have recently taken, experimental drugs as part of another clinical trial
  • You are allergic to the drug or any of its ingredients used in this trial
  • You are pregnant or breastfeeding

Trial design

This is a phase 2 study. The researchers need 1 or 2 children and young people from the UK to take part.

You have ABT-414 as a drip into a vein every 2 weeks. You can have it for up to a year as long as it is helping you and the side effects aren’t too bad.

ABT-414 can cause eye problems. To help with this you have eye drops before and after each treatment.

Samples for research
The team will take blood samples to find out what happens to ABT-414 in the body.

They will also ask for another blood sample. They will use this sample to find out why some people may benefit more from having ABT-414. You don’t have to agree to this one if you don’t want to. You can still take part in the trial.

Hospital visits

You see the doctor to have some tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • MRI scan
  • heart trace (ECG Open a glossary item)
  • eye tests
  • completion of questionnaires

You go to hospital to have ABT-414. You should not need to stay overnight. During treatment you see the doctor who checks how you are. You have regular:

  • physical examinations
  • blood tests
  • MRI scans
  • eye tests

You have an MRI scan every 8 weeks.

At 5 weeks and 7 weeks after finishing treatment you see the doctor for:

  • a physical examination
  • eye test
  • blood tests

You then see the doctor every 6 months for 5 years and then once a year. 

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:

  • you have severe side effects
  • your side effects aren’t getting any better
  • your side effects are getting worse

ABT-414 is a new drug and there may be side effects we don’t know about yet. The most common side effects reported so far include:

  • blurred vision
  • tiredness and lack of energy
  • dry eyes
  • headache
  • inflammation of cornea (keratitis)
  • sensitivity to light
  • eye pain
  • changes to the way the liver works
  • small cysts on the outer covering of the eye (cornea)

You will be given eye drops before and after each treatment to try and reduce these eye problems happening.

While you are having ABT-414 the nurses and doctor will monitor you closely.

Your doctor will talk to you about the possible side effects before you agree to take part in the trial.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Paul Mulholland

Supported by

AbbVie

Freephone 0808 800 4040

Last review date

CRUK internal database number:

14716

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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