“I think it’s really important that people keep signing up to these type of trials to push research forward.”
A trial looking at high dose methotrexate and glucarpidase for people recently diagnosed with primary lymphoma of the brain or spinal cord
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This trial looked at high dose methotrexate with a drug called glucarpidase for people with lymphoma that started in the brain or spinal cord (primary central nervous system lymphoma). This trial was supported by Cancer Research UK.
Primary central nervous system lymphoma is a very rare type of non Hodgkin lymphoma. Doctors usually treat it with high doses of a
In this trial, doctors hoped to give higher doses of methotrexate as they thought it might work better than standard high dose treatment. But higher doses can have harmful side effects such as kidney damage and a severe drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness.
Glucarpidase is a drug that breaks down methotrexate in the body very quickly. This means that it might protect you from some of the harmful side effects of high dose methotrexate. Doctors thought it would be safe to have higher doses of methotrexate if you had it with glucarpidase.
The aims of the trial were to find out
- If higher dose methotrexate with glucarpidase was safe
- The highest dose of methotrexate people could have safely with glucarpidase
- How well the treatment worked
- More about the side effects and quality of life
Summary of results
This was a phase 1 trial. In this trial the first couple of people had a standard dose of methotrexate with glucarpidase. If they didn’t have any serious side effects then the next few would have a higher dose of methotrexate and so on until they found the highest dose they could give safely. This is called a dose escalation study.
Although the trial team found that glucarpidase did work as expected, they closed the trial early. They intended to recruit 18 people but decided to stop recruiting after the first 4 people had their methotrexate and glucarpidase. They did this because 1 of the people had serious kidney damage (although temporary) after having methotrexate. And another person had unexpected side effects that may or may not have been caused by the trial treatment. The trial team decided this made it unsafe to continue.
The trial team concluded that glucarpidase did break down methotrexate in the body as expected. But they couldn’t increase the dose of methotrexate. This was possibly because the kidney damage caused by high dose methotrexate may happen before the glucarpidase could work.
We have based this summary on information from the team who ran the trial. The information they sent us has been reviewed by independent specialists (
How to join a clinical trial
Dr Rod Johnson
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
National Institute for Health Research Cancer Research Network (NCRN)
University College London (UCL)
This is Cancer Research UK trial number CRUK/08/010.