A trial of nab-paclitaxel for children who have cancer that is not responding to treatment or has come back

Cancer type:

Children's cancers
Ewing's sarcoma
Neuroblastoma
Sarcoma
Soft tissue sarcoma

Status:

Open

Phase:

Phase 1/2

This trial is looking at a drug called nab-paclitaxel. It is for children and young people who have a solid tumour that has not responded to treatment or has come back afterwards. A solid tumour Open a glossary item is any cancer other than lymphoma or leukaemia.

This trial is for children and young people up to and including the age of 24. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.

More about this trial

Doctors use various treatments to treat cancer in children and young people. But sometimes a cancer doesn’t respond to treatment as well as hoped, or comes back later on. Researchers are looking for new treatments for children in this situation. In this trial, they are looking at a drug called nab-paclitaxel (also called Abraxane).

Nab-paclitaxel is the chemotherapy drug paclitaxel combined with a protein called albumin.

The aims of this trial are to

  • Find the highest safe dose of nab-paclitaxel that children and young people can have
  • See how much the drug helps children and young people with certain types of cancer

Who can enter

This trial is in 2 parts. You may be able to join part 1 if you are at least 6 months old, but haven’t yet reached your 18th birthday and

  • Have any type of solid tumour Open a glossary item apart from cancer that started in your brain or that has spread to your brain
  • Have cancer that has got worse despite having standard treatment Open a glossary item, or there is no standard treatment available

You may be able to join part 2 if you are between 6 months and 24 years old and have one of the following

And

  •  Your cancer can be measured using a scan and has got worse despite having 1 or 2 other types of treatment

As well as the above, to join either part of the trial all of the following must apply. You

  • Are well enough to take part (this means a Karnofsky or Lansky performance status score of at least 70)
  • Have satisfactory blood test results
  • Are willing to use reliable contraception during the trial and for up to 6 months afterwards if you are sexually active and there is any chance you or your partner could become pregnant

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

  • Have had a low dose of the drug cyclophosphamide in the last 7 days, or other types of chemotherapy or radiotherapy in the last 3 weeks
  • Have had major surgery in the last 2 weeks, or minor surgery in the last week
  • Haven’t recovered from an injury or from the side effects of earlier chemotherapy, radiotherapy or surgery
  • Have had any other experimental drug in the last 4 weeks
  • Have had a biological therapy in the last week
  • Have had a drug called a monoclonal antibody in the last 4 weeks (or earlier if there’s a chance some of the drug could still be in your body)
  • Have had a stem cell transplant in the last 3 months
  • Have damage to the nerves in your hands or feet (peripheral neuropathy) unless this is only mild
  • Have ever had a heart attack, a stroke, or a condition where the blood flow to your legs is restricted (peripheral vascular disease)
  • Have had a blood clot in a deep vein (deep vein thrombosis or DVT) in the last 3 months
  • Are HIV positive
  • Have any other medical condition or mental health problem that could affect your taking part
  • Are pregnant

Trial design

The trial is in 2 parts. The researchers need between 12 and 40 children to join part 1. They need up to 69 children and young people to join part 2. Everybody taking part has nab-paclitaxel.

In the first part of the trial, the researchers are looking for the highest safe dose of nab-paclitaxel that children under 18 can have. The first few patients taking part will have a low dose. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose. This is called a dose escalation study.

In the second part of the trial, the researchers want to see how much nab-paclitaxel helps children and young people with neuroblastoma or Ewing’s sarcoma. Doctors are no longer looking for people with rhabdomyosarcoma to take part. Everybody joining this part of the trial will have the highest safe dose that was found in part 1.

Whichever part of the trial you join, you have nab-paclitaxel through a drip into a vein once a week for 3 weeks, followed by a week without treatment. Each 4 week period is called a cycle of treatment. As long as you don’t have bad side effects, you can carry on having the trial treatment for as long as it helps you.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

  • Physical examination
  • Blood tests
  • Heart trace (ECG Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item) or MUGA scan Open a glossary item
  • CT scan or MRI scan

If you have neuroblastoma you also have a urine test and a scan that uses a very small amount of radioactive iodine to show up the cancer cells. This is called an MIBG scan.

You go to hospital 3 times in each 4 week cycle of treatment. You have a physical examination and blood tests each time.

If you are in part 1 of the trial you may have some extra blood tests in the first few days of treatment. The researchers use these blood samples to look at what happens to nab-paclitaxel in your body. This is called pharmacokinetics Open a glossary item.

During treatment, you have a CT or MRI scan, a heart trace and a heart scan every 8 weeks. If you have neuroblastoma, you also have an MIBG scan at these times.

When you finish treatment, you see the trial team again 4 weeks later. After that, they will contact you once a month for up to a year to see how you are.

Side effects

As this is the first time that nab-paclitaxel has been tested in children, there may be side effects we don’t know about yet. In adults, the most common side effects include

Location

Sutton

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 Julia Chisholm

Supported by

Celgene Corporation
NIHR Clinical Research Network: Cancer

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

11890

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

Over 60,000 cancer patients enrolled on clinical trials in the UK last year.

Last reviewed:

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