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

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bone cancer

Sarcoma

Status:

Closed

Phase:

Phase 2

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 Open a glossary item 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.

Who can enter

You can enter this study if you

Have osteosarcoma and the cells are very abnormal (high grade), or a type of bone cancer called spindle cell sarcoma
Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
Have satisfactory blood tests
Are willing to use reliable contraception if there is any chance you or your partner could become pregnant
Are aged between 5 and 50 years

You cannot enter this study if you

Are still having treatment for your bone cancer, including treatment as part of another clinical trial, or you have not yet recovered from side effects of previous treatment
Have already had glucarpidase
Are taking any medication that could affect how the body uses or gets rid of methotrexate chemotherapy – you can check this with your doctor
Have fluid collection, for example in your lungs or tummy area (abdomen)
Are pregnant or breastfeeding

Trial design

This study will recruit 38 people. The people taking part are put into one of 2 groups randomly. Neither you nor your doctor will be able to decide which group you are in.

Everybody taking part has methotrexate, folinic acid and glucarpidase. You have treatment in 3 week periods called cycles of treatment. The difference between the 2 groups is whether you have glucarpidase in the first cycle of treatment or in the second.

You have high dose methotrexate on days 1 and 8 of each treatment cycle. You have it through a drip into a vein or central line. It takes 4 hours each time. You will also have lots of fluids through your drip before, during and after your methotrexate, to help flush it out of your body.

You start folinic acid either as a tablet, or as an injection into your vein or central line, 24 hours after you start methotrexate. You have a blood test each day to see how much methotrexate is left in your body. When it has nearly all gone, you stop folinic acid and can go home.

Everybody has 2 cycles of treatment.

If you are in group 1, you have glucarpidase in the second cycle of treatment. You have it as an injection into a vein or central line 2 hours before you start folinic acid.

If you are in group 2, you have glucarpidase in the same way, but in your first cycle of treatment.

There are 2 questionnaires for this study that you complete 6 times each. These ask about side effects and about how you have been feeling. They are called quality of life studies.

Everyone will also have up to 15 extra blood tests for the study. These blood tests check chemotherapy levels in your blood, and also look for glucarpidase antibodies Open a glossary item .

Hospital visits

Before you start the study you will see the doctor and have some blood tests.

You then come to hospital for each methotrexate treatment, and stay until the methotrexate has nearly all left your system. This usually takes about 4 days.

On day 15 of each cycle of treatment, you will see a member of the study team and have a blood test. You will also fill out some quality of life questionnaires.

After the study you will have another blood test

1 month
3 months
6 months

after starting your second cycle of chemotherapy. The team will try to fit these in with your routine hospital visits where possible.

After the study you continue to see your regular cancer specialist, in the same way as before.

Side effects

Side effects of glucarpidase include pins and needles (paresthesia).

It is possible you may have a severe allergic reaction (anaphylaxis) to glucarpidase if you have had this drug before. Glucarpidase may also have other side effects that we don’t know about yet.

Side effects of methotrexate include

Loss of appetite
Feeling sick
Tiredness
Hair loss
A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
Sore mouth and tummy
Changes to the way your kidneys work
Rash on your hands and feet (hand foot syndrome – this is rare)

Recruitment start:

30/07/2007

Recruitment end:

30/06/2015

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

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)

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

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