A trial looking at temozolomide for rhabdomyosarcoma

You may be able to enter this trial if you

• Have rhabdomyosarcoma that did not respond to treatment or has come back
• Have sarcoma that can be measured on CT scan or MRI scan
• Are aged between 6 months and 50 years old
• Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1) or have a Lansky play score of 70% - 100% if you are under 12
• Have satisfactory blood test results
• Are willing to use reliable contraception during treatment and for 6 months afterwards if you are sexually active and there is any chance that you or your partner could become pregnant

You cannot enter this trial if you

• Have had radiotherapy in the last 3 weeks unless it was to control symptoms of the cancer (palliative radiotherapy)
• Have had irinotecan or temozolomide in the past
• Have had drugs called vincristine, vinorelbine, vinblastine or cyclophosphamide in the last 2 weeks, or any other chemotherapy that causes a drop in the number of blood cells in the last 3 weeks (6 weeks if you had a drug called a nitrosourea)
• Are allergic to the drugs in the trial
• Have diarrhoea that is causing you a problem
• Have an infection that cannot be treated
• Have any other medical problems that the trial doctors think could affect you taking part
• Are taking any medicine to prevent fits such as phenytoin, phenobarbital, or carbamazepine
• Are taking certain other drugs such as rifampicin, voriconazole, itraconazole, ketoconazole or aprepitant – the trial doctors can advise you about this
• Are pregnant or breastfeeding

The trial will recruit 80 people in Europe. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.   

• People in group A have vincristine and irinotecan
• People in group B have vincristine, irinotecan and temozolomide

People in both groups have vincristine and irinotecan through a drip into a vein every 3 weeks. Each 3 week period is called a cycle of treatment. People in group B also take temozolomide tablets daily for 5 days every 3 weeks. Everybody taking part has up to 12 cycles of treatment.

If you have a central line (Hickman or long line), you can have your treatment through this.

You will see the doctors and have some tests before you start treatment. The tests include

• Blood tests
• Physical examination
• CT scan or MRI scan
• Bone scan
• PET scan
• Bone marrow test

While you are having treatment you see the doctor and have blood tests frequently. You have CT scans or MRI scans every 6 weeks.

When you finish treatment, you see the trial team, have a blood test and a CT or MRI scan. You may also have a PET scan and bone marrow test.

You then see the trial team and have a CT or MRI scan

• Every 3 months for 2 years
• Every 6 months for 3 years

The most common side effects of vincristine are

• Constipation
• Tiredness (fatigue)
• Feeling or being sick
• Hair loss
• Numbness and tingling in your hands and feet (peripheral neuropathy)

The most common side effects of irinotecan are

• Diarrhoea
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

The most common side effects of temozolomide are

• Tiredness (fatigue)
• Headaches
• Constipation
• Feeling or being sick
• A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness

There is more information about vincristine, irinotecan and temozolomide in our cancer drugs section.