
"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at dalotuzumab alone and in combination with ridaforolimus for children and young people who have an advanced solid tumour or lymphoma (but not leukaemia).
The trial is for children and young people up to (and including) 17 years old. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
Dalotuzumab (MK-0646) is a type of biological therapy called a monoclonal antibody. These can seek out cancer cells by looking for particular proteins.
Ridaforolimus (MK-8669) is also a type of biological therapy. It is a cancer growth blocker. It stops signals that cancer cells use to divide and grow.
This trial is in 3 parts. The first part is looking at dalotuzumab alone. Parts 2 and 3 are looking at dalotuzumab in combination with ridaforolimus.
The aims of this trial are to find out
You may be able to enter this trial if you
You cannot enter this trial if you
This is a phase 1 trial that is being done in 3 parts. It will recruit 40 to 60 children and young people from America and Europe, including the UK.
The first part is what’s known as a dose escalation trial. This means that the first few people taking part will have the lowest dose. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give.
If you join this part of the trial you will have dalotuzumab alone. You have this through a drip into a vein, once every 3 weeks.
The second part of the trial is also a dose escalation trial. The first few people will have the lowest dose of both dalotuzumab and ridaforolimus. The next few people will have a higher dose, and so on. You have dalotuzumab through a drip into a vein every 3 weeks. And you take ridaforolimus tablets once a day for 5 days each week.
If you join the third part of the trial you will have dalotuzumab and ridaforolimus. The dose you have will depend on the best doses found in part 2 of the trial. You have dalotuzumab through a drip into a vein every 3 weeks. And you take ridaforolimus tablets once a day for 5 days each week.
You will have treatment for as long as the doctors think it’s helping you. If there are signs that your cancer has started to grow again or your have serious side effects, the doctors will probably decide to stop treatment. If this happens, you will continue to see your own doctor for treatment.
You will see the doctors and have some tests before you start the trial. The tests include
You will see the doctors and have blood tests regularly during the trial. Exactly when will depend on which part of the trial you join.
You have a CT or MRI scan every 6 weeks during treatment. You will have another CT or MRI scan, blood tests and a physical examination about 4 weeks after you finish treatment.
As dalotuzumab and ridaforolimus are quite new drugs, there may be side effects that doctors don’t know about yet.
Possible side effects of dalotuzumab include
Possible side effects of ridaforolimus include
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Andrew Pearson
Experimental Cancer Medicine Centre (ECMC)
Merck
Sharp & Dohme
National Institute for Health Research Cancer Research Network (NCRN)
Freephone 0808 800 4040
"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."