A study looking at the way carboplatin, cyclophosphamide and etoposide chemotherapy works in children under two with cancer (PK 2006 09)

Cancer type:

Children's cancers

Status:

Results

Phase:

Other

This study found out more about how chemotherapy worked in children under 2 years of age with any type of cancer.

This trial was open for children to join between 2007 and 2013. The team published their first results in 2021. 

More about this trial

Doctors use chemotherapy to treat children and adults. But they know very little about what happens to these drugs in very young children.

Younger children’s liver and kidneys are still developing. This can affect how their bodies get rid of the chemotherapy drugs.

Researchers wanted to find out more about how their bodies got rid of chemotherapy drugs. And what factors affect the levels in the blood. 

The researchers took blood samples from children under 2. They measured drug concentrations in their blood at different times. This was a pharmacokinetic  Open a glossary itemstudy.

Summary of results

These are the first results from this study. When the study team publish more results we will update this summary. 

About this study
25 children between 4 months and 23 months old took part in this study. They had different cancers such as:

  • leukaemia Open a glossary item
  • neuroblastoma Open a glossary item
  • brain tumours Open a glossary item
  • PNET Open a glossary item

They all had cyclophosphamide as part of their treatment. How much cyclophosphamide the children had depended on:

  • their height and weight
  • the treatment schedule for their cancer  

 Between the children the team took 111 blood samples. 

Results
In the body cyclophosphamide breaks down into certain products. The study team looked at these drug breakdown products in the blood samples to see how the body got rid of the cyclophosphamide.

The team looked at how much of the drug and breakdown products were in each blood sample. 

They found there was no major difference in the amount of these substances between the blood samples. 

The team also compared these results with older people who had cyclophosphamide. This suggested that there are differences between young children and older people. 

Conclusion
The study team concluded there was no difference between how children under 2 got rid of cyclophosphamide. It did show there was a difference in how young children clear the drug from the body compared to older children. They suggest further studies to compare differences between different ages of children. 

The study did highlight the large differences of the dose of cyclophosphamide used in the different cancer types. They suggest more studies to look at whether it is better to give a low dose over several days or a higher dose on one day. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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

Professor Gareth Veal

Supported by

Cancer Research UK
Children's Cancer and Leukaemia Group (CCLG)
Experimental Cancer Medicine Centre (ECMC) 
NIHR Clinical Research Network: Cancer 
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Northern Institute for Cancer Research
University of Newcastle

Freephone 0808 800 4040

Last review date

CRUK internal database number:

1105

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

Katie took part in a new clinical trial

A picture of Katie cycling

"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."

Last reviewed:

Rate this page:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think