A trial looking at temozolomide for rhabdomyosarcoma (VIT-0910)

Cancer type:

Children's cancers
Sarcoma
Soft tissue sarcoma

Status:

Results

Phase:

Phase 2

This trial looked at adding temozolomide to chemotherapy for people with rhabdomyosarcoma Open a glossary item. It is a type of soft tissue sarcoma. 

It was for children and adults whose sarcoma had come back or treatment had stopped working. 

The trial was supported by Cancer Research UK.

It was open for people to join between 2012 and 2018. The team published the results in 2021.

More about this trial

This trial was for children over 6 months old and adults up to 50 years old.  

There are a number of treatment options for rhabdomyosarcoma. Sometimes the treatment stops working or the cancer comes back afterwards. When this trial was done people may then have had 2 chemotherapy drugs. These are called vincristine and irinotecan

Doctors were looking for ways to improve this treatment. In this trial, they looked at adding another chemotherapy drug called temozolomide. At the time of the trial it was a treatment for some other cancer types. 

The aims of the trial were to:

  • find out if temozolomide, irinotecan and vincristine work better than irinotecan and vincristine
  • learn more about the side effects

Summary of results

The team found that adding temozolomide to vincristine and irinotecan improved treatment. Some of the side effects were worse but the team say these were manageable. 

Trial design
This was a phase 2 trial. 120 people took part. The median Open a glossary item age was 11 years old.

People were put into a treatment group at random

  • 60 people had vincristine and irinotecan (VI group)
  • 60 people had vincristine, irinotecan and temozolomide (VIT group)

Everybody taking part had up to 12 cycles of treatment Open a glossary item for as long as it was working and the side effects weren’t too bad. Each cycle of treatment was 3 weeks. 

Results
The trial team followed everyone up for about 57 months. They looked at how well treatment worked. 

In the vincristine and irinotecan group the researchers had the results for 58 people. They found the cancer:

  • went away completely in 4 people
  • shrunk a little bit in 18 people
  • stayed the same in 17 people
  • got worse in 19 people

In the VIT group the researchers had the results for 58 people. They found the cancer:

  • went away completely in 9 people
  • shrunk a little bit in 24 people
  • stayed the same in 16 people
  • got worse in 9 people

The researchers looked at how long before the cancer started to grow again. They found it was:

  • 3.2 months for those who had vincristine and irinotecan
  • 4.7 months for those who had vincristine, irinotecan and temozolomide

They also looked at how long people lived. They found it was:

  • 10.3 months for those who had vincristine and irinotecan
  • 15 months for those who had vincristine, irinotecan and temozolomide

Side effects
Everybody had at least one side effect. The most common severe side effects were:

  • a drop in white blood cells  Open a glossary itemcausing an increased risk of infection
  • a drop in red blood cells Open a glossary item causing tiredness and breathlessness
  • high temperature and low white blood cells (febrile neutropenia)
  • diarrhoea
  • feeling or being sick 
  • weight loss

A few more people who had VIT had these side effects. 

We have information about:

Conclusion
The team concluded that temozolomide, vincristine and irinotecan improved treatment for rhabdomyosarcoma that had come back. It increased the length of time that people lived.

Vincristine, irinotecan and temozolomide may now be the new standard treatment Open a glossary item for this group of people.

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

Dr Julia Chisholm

Supported by

Cancer Research UK
Cancer Research UK Children's Cancer Trials Team
Centre Oscar Lambret
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Birmingham

Other information

This is Cancer Research UK trial number CRUK/11/019.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

8276

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

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

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