RecruitingPHASE1, PHASE2INTERVENTIONAL

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

This research study, called 'Precision Therapy for Relapsed Childhood Cancers', is designed for children and young people under 18 whose cancer has come back or isn't responding to standard treatments. It's an early-stage study (Phase 1/2), meaning researchers are testing new drugs or drug combinations to find a safe and effective dose, and to see if they show signs of working. The study focuses on matching treatments to specific changes found in a patient's cancer cells. This 'basket' approach allows them to test several different cutting-edge medicines, like Ribociclib, Olaparib, and Nivolumab, that target various ways cancer grows. The aim is to find more effective and personalised ways to tackle difficult-to-treat childhood cancers in Europe.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrolment target

472

Start

03 Aug 2016

Estimated completion

01 Feb 2031

Pediatric Cancer

What is this study about?

This research study, called 'Precision Therapy for Relapsed Childhood Cancers', is looking for better ways to treat cancer in children and young people. Sometimes, childhood cancers don't respond to the usual treatments, or they come back after treatment. For these children, doctors need new options.

This study is special because it tries to match the treatment to the unique features of each child's cancer. Think of it like a detective looking for clues in the cancer cells to find their weaknesses. Once these weaknesses are found, specific medicines are chosen that are designed to attack those weaknesses. This is called a 'precision medicine' approach. The study aims to find the right dose for these new medicines and see if they can help shrink the cancer or stop it from growing.

By testing several different medications that target various ways cancer can grow, this study hopes to open doors to more effective and personalised treatments for young patients across Europe. This is an early-stage study, meaning the researchers are carefully checking for safety and looking for early signs that the treatments are working, with the ultimate goal of improving outcomes for children with challenging cancers.

Key takeaways

This study offers new treatment options for children with hard-to-treat cancers.
It uses a 'precision medicine' approach, matching treatment to your child's cancer type.
It's an early-stage study, aiming to find safe doses and signs of effectiveness.
Your child's cancer must have been previously profiled through special genetic tests.
Participation includes regular check-ups, tests, and monitoring for side effects.
Your child can withdraw from the study at any time.

Who may be eligible?

This study is for children and young people who have a type of cancer that has either come back after treatment, or where standard treatments haven't worked or aren't available. Most participants will be under 18, but older young people might be included if their cancer is typically seen in children and has returned or is hard to treat.

For you to be considered, doctors need to have already looked very closely at your child's cancer cells through special tests. These tests help them find specific changes within the cancer that the new medicines in this study are designed to target. Your child also needs to be well enough to take part, meaning they can move around and perform daily activities reasonably well, and their important organs like their heart and blood system are working properly. They should also have a life expectancy of at least three months.

Doctors will carefully check various medical details to make sure the study is a safe and suitable option for your child. They will look at things like blood counts and how well their heart is functioning, especially if they've had certain treatments before.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child under 18 (or an older young person with a childhood cancer)?
Has my child's cancer come back or not responded to standard treatments?
Have special tests already been done on my child's cancer cells to find specific changes?
Is my child generally well and able to get around, and are their major organs working properly?
Does my child have a life expectancy of at least 3 months?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will receive one or more of the new medications being tested. The specific drug or combination will depend on the unique features of their cancer identified by the special tests. Throughout the study, your child will have regular appointments for check-ups, blood tests, and scans to see how the treatment is working and monitor for any side effects. The study involves different stages called phases. In earlier phases, the main aim is to find the safest and most effective dose. In later phases, the focus is on seeing how well the treatment works against the cancer. The total length of time your child might be in the study will vary, depending on their response to treatment and the specific study plan for their group.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which may be helpful if standard treatments haven't worked for your child. However, there are also potential risks, as these are new medicines and their full effects may not be known. Side effects can occur, and some may be serious. The research team will explain all known risks and monitor your child closely. It's important to remember that your child can withdraw from the study at any time, for any reason, without it affecting their future medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Rigshospitalet
Verified postcode
Copenhagen, Denmark· Recruiting
Gustave Roussy
Verified postcode
Villejuif, France· Recruiting
CHU Angers
Verified postcode
Angers, France· Recruiting
CHU Pellegrin
Verified postcode
Bordeaux, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Hôpital de La Timone
Verified postcode
Marseille, France· Recruiting
CHU Nantes
Verified postcode
Nantes, France· Recruiting
Institut Curie
Verified postcode
Paris, France· Recruiting
Hôpital Armand Trousseau
Verified postcode
Paris, France· Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Verified postcode
Milan, Italy· Recruiting
Ospedale Infantile Regina Margherita
Verified postcode
Torino, Italy· Not yet recruiting

Common questions

What kind of cancer is this study for?

This study is for children and young people with blood cancers or solid tumours that have come back or haven't responded to usual treatments.

What does 'precision medicine' mean in this study?

It means the doctors use special tests to look at your child's cancer cells and pick a medicine that specifically targets the weaknesses found in those cells, rather than a general treatment.

Will my child get a new treatment if they join?

Yes, your child will receive one or more of the new medications being tested in this study, which are designed to target specific features of their cancer.

What are the phases of the study and what do they mean?

Phase 1 studies find the safest dose of a new drug, while Phase 2 studies look to see if the drug shows promise in treating the cancer effectively.

What if my child decides they don't want to continue in the study?

Your child can stop participating in the study at any time, for any reason. This will not affect their future medical care.

How to find out more

Birgit Geoerger, MD

birgit.geoerger@gustaveroussy.fr +33 (0)1 42 11 46 61 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.