A trial of ABT-414 for glioblastoma that has come back (INTELLANCE 2)

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

Status:

Closed

Phase:

Phase 2

This trial is looking at a new drug called ABT-414 with or without temozolomide for glioblastoma that has come back after treatment. It is open to people whose glioblastoma has a larger number of receptors Open a glossary item for the protein called epidermal growth factor (EGF Open a glossary item). With your permission the researchers will test a sample of your tumour tissue to find this out.

More about this trial

Doctors can use chemotherapy to treat glioblastoma that has come back after treatment. Temozolomide and lomustine are 2 chemotherapy drugs they can use. These work but researchers are always looking to improve treatment.

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 Open a glossary item 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. An earlier study suggests that people whose glioblastoma has a large number of EGF receptors may benefit from ABT-414.

In this trial the researchers want to compare

  • ABT-414
  • ABT-414 and temozolomide
  • Standard treatment Open a glossary item

The aims of this trial are to

  • Find out which treatment is better for glioblastoma that has come back
  • Find out how safe ABT-414 is alone and in combination with temozolomide

Who can enter

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

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

  • You have glioblastoma that has a large number of receptors Open a glossary item for the protein called epidermal growth factor (EGF) Open a glossary item and has come back after treatment with radiotherapy and temozolomide
  • Your glioblastoma came back at least 3 months after the end of radiotherapy or had come back in an area that wasn’t treated with radiotherapy
  • If you have had surgery to remove the area where the tumour had come back it must have been more than 2 weeks ago and you have fully recovered
  • You have had an MRI scan Open a glossary item within 2 weeks of being randomised for this trial. If you are taking steroids you must be taking a stable or decreasing dose a week before the MRI
  • You are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • You have satisfactory blood test results
  • You are willing to use reliable contraception during treatment and for 6 months afterwards if you or your partner could become pregnant
  • You are at least 18 years old

You cannot join this trial if any of these apply. You

  • Have had more than 1 course of chemotherapy treatment
  • Have had chemotherapy within the 4 weeks of being randomised into the trial
  • Have had a nitrosourea Open a glossary item chemotherapy drug for example lomustine
  • Have had bevacizumab
  • Stopped taking temozolomide due to side effects
  • Have had more than 65 Gray Open a glossary item (Gy) of radiotherapy
  • Have had stereotactic radiosurgery or brachytherapy Open a glossary item unless you have had a biopsy Open a glossary item that confirms the glioblastoma has come back after having these treatments
  • Take anti convulsant medication that affects body substances called CYP enzymes unless you can change to ones that don’t affect CYP enzymes at least 2 weeks before being randomised in this trial
  • Are planning to have a live vaccination Open a glossary item
  • Have taken an experimental drug as part of another clinical trial within 4 weeks of being randomised
  • Are allergic to the drugs used in this trial or any of their ingredients
  • Have had another cancer in the past 5 years apart from successfully treated non melanoma skin cancer Open a glossary item or in situ carcinoma of the cervix
  • Have coeliac disease or a wheat allergy
  • Have any other medical or mental health condition that the trial team think could affect you taking part
  • Are pregnant or breastfeeding

Trial design

This is an international phase 2 trial. The researchers need at least 18 people from the UK to join. You can register your interest in joining the trial. If you do this the trial team will contact you about testing a sample of your brain tumour tissue tested for EGFR. The sample will be from when you had surgery or a biopsy in the past.

It is a randomised trial. The people taking part are put into 1 of 3 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

  • People in one group have ABT-414 and temozolomide
  • People in another group have ABT-414
  • People in another group have standard treatment (lomustine or temozolomide)

Diagram for INTELLANCE 2

For people in the standard treatment group whether you have lomustine or temozolomide depends on how long it took for your glioblastoma to come back. Your doctor will talk to you about this.

You have ABT-414 as a drip into a vein every 2 weeks. ABT-414 can cause eye problems. To help with this you will have eye drops before and after each treatment.

Temozolomide is a capsule you take for 5 days every 4 weeks. You take them on an empty stomach at least 2 hours after a meal.

Lomustine is a capsule you take on one day every 6 weeks.

You can continue taking ABT-414 and temozolomide as long as it is helping you and the side effects aren’t too bad.

As long as it is helping you and the side effects aren’t too bad you can continue taking lomustine for up to a year.

If you are taking temozolomide you take home a diary. This is to fill in the dates and times you had it.

The trial team will ask you to fill out 2 questionnaires before you start treatment, twice during treatment and 6 months after being put into your treatment group. The questionnaires will ask about side effects and how you’ve been feeling. This is called a quality of life study.

The researchers need to do further testing on the sample of your cancer that was used to see if your tumour was EGFR positive. This is to find out more about glioblastoma and why some people do better than others during treatment. After the researchers have completed the testing they need to do as part of the trial, they may ask if they can keep any remaining tissue for further research.

They will also ask for extra blood samples. They will use these samples to find out why some people may benefit more from having ABT-414. If you don’t want to give these blood samples for research, you don’t have 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
  • An examination to see how well your brain and nerves work (neurological examination)
  • Blood tests
  • Eye test by a specialist eye doctor (an ophthalmologist)
  • Heart trace (ECG Open a glossary item)
  • MRI scan of the brain

During treatment you see the doctor regularly for

  • A physical examination
  • A neurological examination
  • Blood tests
  • MRI scan of the brain (every 8 weeks)

You may have more eye tests done if needed. If you are having ABT-414 you will have 2 more heart traces.

After treatment you see the doctor or the team will phone you every 3 months.

Side effects

ABT-414 is a new drug and there might be side effects we don’t know about yet.

ABT-414 can cause small cysts on the surface of the eye (cornea). When this happens it can cause problems with your eyes including

  • Blurred vision
  • Dry eyes
  • Swelling of the eye tissue
  • Eye pain
  • Itchy eyes
  • Inflammation of the cornea
  • Sensitivity to light
  • Watery eyes
  • Feeling like something is in your eye

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

Other common side effects include

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

We have information about the side effects of temozolomide and lomustine.

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
Experimental Cancer Medicine Centre (ECMC)
European Organisation for Research and Treatment of Cancer (EORTC)

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

13514

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

Rhys was only four years old when he was diagnosed with a brain tumour

A picture of Rhys

"He went through six operations and was placed on a clinical trial so he could try new treatments.”

Last reviewed:

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