"We believed that with the clinical trial, Katie had the best chance of recovery. Without these trials, amazing new treatments may never be found."
A trial looking at dalotuzumab and ridaforolimus for children and young people with advanced cancer (MK-8669-062)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Children's cancers
Status:
Closed
Phase:
Phase 1
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
- The best dose of dalotuzumab and ridaforolimus to give
- What happens to these drugs in the body
- More about the side effects
Who can enter
You may be able to enter this trial if you
- Have been diagnosed with a solid tumour or lymphoma that has continued to grow despite treatment, or there is no standard treatment available to you
- Have an area of cancer that can be measured on a scan
- Are able to swallow tablets
- Are well enough to be up and about and can play for at least some of the day - this is called performance status
- Have satisfactory blood test results
- Are willing to use reliable contraception during treatment and for a month afterwards if there is any chance that you or your partner could become pregnant
- Are between 3 and 17 years old for part 1, or between 6 and 17 years old for parts 2 and 3
You cannot enter this trial if you
- Have been diagnosed with leukaemia
- Have had dalotuzumab before
- Are taking part in any other clinical trial
- Are still having side effects from treatment you’ve had
- Know you have HIV, Hepatitis B or Hepatitis C (you won’t be tested as part of this trial)
- Have diabetes that is not well controlled
- Are pregnant or breast feeding
Trial design
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.
Hospital visits
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.
Side effects
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
- An increase in blood sugar level
- Tiredness (fatigue)
- Diarrhoea
- Feeling or being sick
- Weight loss
Possible side effects of ridaforolimus include
- Sore mouth or throat
- Tiredness (fatigue)
- Rash, dry or itchy skin
- Loss of appetite
- A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- Feeling or being sick
- Diarrhoea
- Increase level of fat in the blood
Recruitment start:
Recruitment end:
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.
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Chief Investigator
Professor Andrew Pearson
Supported by
Experimental Cancer Medicine Centre (ECMC)
Merck
Sharp & Dohme
National Institute for Health Research Cancer Research Network (NCRN)
Freephone 0808 800 4040
Last review date
CRUK internal database number:
Oracle 9152
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
Katie took part in a new clinical trial
