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A study looking at a drug to help reduce side effects of methotrexate in people with some types of bone cancer

Overview

Cancer types:

Bone cancer, Sarcoma

Status:

Closed

Phase:

Phase 2

Details

This study is looking at adding a drug called glucarpidase to folinic acid after methotrexate chemotherapy. It is for people with a bone cancer called osteosarcoma or spindle cell sarcoma.

This study is for children over the age of 5 and adults up to the age of 50. We use the term ‘you’ in this summary, but of course if you are a parent, we are referring to your child.

Methotrexate is one of the chemotherapy drugs that works best for osteosarcoma. But it can cause a sore mouth, pain in the tummy (abdomen) and an increased risk of infection. Doctors try to reduce side effects by giving a vitamin called folinic acid. You have folinic acid 24 hours after methotrexate, and then regularly until the methotrexate levels are really low in your bloodstream. But even with this, side effects are still a problem and many people can’t have their next chemotherapy on time.

In this study researchers will look at adding a drug called glucarpidase to folinic acid. Glucarpidase is an enzyme that stops methotrexate working in the bloodstream. Lower levels of methotrexate mean fewer side effects.

The main aim of this study is to see if glucarpidase helps people to have their next methotrexate dose on time by reducing side effects.

Recruitment start: 30 July 2007

Recruitment end: 30 June 2015

How to join

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Chief investigators

Prof Jeremy Whelan

Supported by

BTG International Ltd

Experimental Cancer Medicine Centre (ECMC)

Richard Scowcroft Foundation

University College London Hospitals NHS Foundation Trust

University College London (UCL)

Last reviewed: 9 July 2015

CRUK internal database number: 5370

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