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

Cancer type:

Testicular cancer

Status:

Results

Phase:

Phase 2

This trial looked at chemotherapy for men with germ cell cancer that had come back after treatment (relapsed).

Germ cells are the cells that produce sperm in males. Male germ cell cancers usually develop in the testicles, but can be found in other parts of the body.

We know from research that a combination of the following drugs can work for most men with relapsed germ cell cancer

But this chemotherapy combination does not work as well for men over the age of 35 or who have high levels of a body chemical, called LDH, when their germ cell cancer comes back. LDH is a tumour marker for testicular cancer that helps doctors to see if the disease has come back.

To see if they could improve treatment, the men in this trial had the chemotherapy combination of G-CSF, dactinomycin, methotrexate, irinotecan and oxaliplatin.

The aims of this trial were to see

If the combination of G-CSF, dactinomycin, methotrexate, irinotecan and oxaliplatin worked for men whose germ cell cancer had come back and who were over 35 with high levels of LDH
How safe this chemotherapy combination was for this group of men and what the side effects were

Summary of results

The trial team found that the combination of G-CSF, dactinomycin, methotrexate, irinotecan and oxaliplatin didn’t work for men whose germ cell cancer had relapsed.

This was a phase 2 trial. The researchers had planned to recruit 47 men but they only recruited 5. Everyone had G-CSF, dactinomycin, methotrexate, irinotecan and oxaliplatin.

Overall, the average length of time the men lived was just under 2 months.

The side effects included

The worst of these was diarrhoea caused by irinotecan. The researchers reduced the dose of irinotecan to see if this helped, but it didn’t. The group that manages the day to day running of the trial (Trial Management Group) decided to stop the trial.

The trial team concluded that because of the side effects, they couldn’t use the combination of dactomycin, methotrexate, irinotecan and oxaliplatin.

We have based this summary on information from the team who ran the trial. As far as we are aware, the information they sent us has not been reviewed independently (peer reviewed Open a glossary item ) or published in a medical journal yet. The figures we quote above were provided by the trial team. We have not analysed the data ourselves.