A trial looking at treatment for men whose germ cell cancer has relapsed (GAMIO)

Who can enter

You can enter this trial if

• You are male with a germ cell tumour
• Your cancer has come back after having cisplatin or continued to grow while having cisplatin
• Your kidneys are working well
• You have satisfactory blood results
• Are well enough to take part (performance status 0 to 3)
• You are willing to use reliable contraception during the treatment and for 6 months after if there is a chance your partner could become pregnant
• You are 16 to 65 years old

Please note if you are 16 to 35 years old you must have at least 1 of the following

• A raised tumour marker called LDH
• A mediastinal non-seminoma germ cell tumour
• You are not able to have any more cisplatin

You cannot enter this trial if you

• Have another cancer except basal cell skin cancer
• Have another serious medical condition that could affect you taking part in this trial
• Are already taking medication as a part of a clinical trial

Trial design

This is a phase 2 trial. It will recruit 12 men to start with. If results are promising, it will go on to recruit another 35, giving a total of 47 men in the trial.

All men taking part will have G-CSF (pegfilgrastim), dactinomycin, methotrexate, irinotecan and oxaliplatin. You have these while you are in hospital. You are in hospital for 2 nights. One week after leaving hospital, you return for a day to have another injection of irinotecan. This makes up one cycle of treatment. You have up to 4 cycles of treatment in total.

You have all the treatment through a drip into a vein (intravenous drip), apart from the G-CSF. You have G-CSF as an injection under the skin.

You may have a central line put in to have the treatment. You can have all your chemotherapy through this so that you don’t have to have repeated injections or drips. Your doctor will discuss this with you.

Hospital visits

You will see the doctor and have some tests before you start treatment.
These tests include

• Physical examination
• Blood tests
• Breathing test (lung function tests)
• PET-CT scan
• MRI scan of the brain

After the 1st cycle of treatment, you have another PET-CT scan.

Before each cycle of treatment you have blood tests and a physical examination.

After the last cycle of treatment you have blood tests, physical examination and a PET-CT scan.

After treatment you see the doctor

• Every month for 1 year
• 2 monthly for the next 6 months
• 3 monthly for the next 18 months
• 4 monthly for the next year
• 6 monthly for the next year

Side effects

The most common side effects of dactinomycin, methotrexate, irinotecan and oxaliplatin are

• A drop in blood cells causing tiredness, an increased risk of infection, bruising and bleeding
• Feeling or being sick
• Tiredness (fatigue)
• Hair loss
• Diarrhoea
• Constipation
• Sore mouth
• Skin rash

The most common side effects of GCSF are

• Skin rash and reddening around the injection site
• Bone pain
• Feeling sick
• Diarrhoea
• Headaches
• High temperature (fever) and chills

You can find more about the side effects of G-CSF, dactinomycin, methotrexate, irinotecan and oxaliplatin on CancerHelp UK.