A5481092: PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
This research is a clinical trial for children and young people with two specific types of cancer: Ewing sarcoma or neuroblastoma. These are cancers that have either returned after treatment or haven't responded well to usual treatments. The study is testing new combinations of existing medicines, including one called palbociclib (Ibrance®), along with other chemotherapy drugs like irinotecan, temozolomide, topotecan, and cyclophosphamide. The main goals are to find out if these combinations are safe for children and how well they work to control the cancer. Researchers will carefully check for any side effects and see if the treatments stop the cancer from growing or spreading.
At a glance
What is this study about?
This study, called A5481092, is looking for better ways to treat certain cancers in children and young people. Specifically, it's for those with Ewing sarcoma or neuroblastoma that have either come back after treatment or haven't responded well to the treatments they've had before. The doctors are trying out new combinations of medicines to see if they can help these patients. They want to find out if these new combinations are safe and if they can stop the cancer from growing.
The study involves giving a medicine called palbociclib (you might hear it called Ibrance®) together with other chemotherapy drugs. There are two main groups being looked at: one group will receive palbociclib with irinotecan and temozolomide, while the other will receive palbociclib with topotecan and cyclophosphamide. These are all medicines that are used to treat cancer, but the study is testing new ways of combining them, especially with palbociclib, which works by stopping certain cancer cells from dividing.
This is a 'Phase 1/2' study, which means it has two main parts. In the first part (Phase 1), the doctors will be very focused on finding the right dose of the medicines and making sure they are safe for children. Once they have a safe dose, the second part (Phase 2) will then look more closely at how well these combinations work against the cancer, such as if they shrink tumours or stop them from spreading. The overall aim is to find more effective and safe treatments for these difficult-to-treat cancers.
Key takeaways
- New drug combinations for specific childhood cancers (Ewing sarcoma, neuroblastoma).
- For cancers that have come back or haven't responded well to treatment.
- Investigating safety and effectiveness of treatments.
- Involves regular hospital visits for assessment and treatment.
- You can stop participating at any time.
Who may be eligible?
This study is for children and young people who have been diagnosed with either Ewing sarcoma or neuroblastoma. It's specifically for those whose cancer has returned after previous treatment or hasn't responded as expected to the treatments they've already had.
To join, a patient must be at least 18 years old. Both male and female patients can take part.
There might be other health requirements or previous treatments that could affect whether someone can join. The study team will review each patient's medical history carefully to make sure they are a good fit and that it's safe for them to participate.
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.
- Are you 18 years old or older?
- Do you have Ewing sarcoma or neuroblastoma?
- Has your cancer returned or not responded well to previous treatments?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive a new combination of medicines. This will involve regular visits to the clinic where you'll have various tests and checks. These checks might include blood tests to look at how your body is handling the medicines, heart scans (ECG), and measurements of your vital signs like blood pressure and temperature. Doctors will also closely monitor you for any side effects.
They will regularly check how your cancer is responding to the treatment, possibly using scans like MRI or CT scans. The study also involves recording how you feel and your quality of life using special questionnaires.
The time you spend on the study will depend on how your treatment is going and how your body responds. There will be initial treatment cycles, followed by ongoing monitoring and follow-up. The total duration of participation will be explained in detail by the study team.
Potential risks and benefits
Locations (5)
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedCzechia
- —UnverifiedSlovakia
- —UnverifiedGermany
Common questions
What types of cancer is this study for?
This study is for children and young people with Ewing sarcoma or neuroblastoma that has come back or not responded to previous treatments.
What medicines are being tested?
The study tests combinations of palbociclib (Ibrance®) with other chemotherapy drugs like irinotecan, temozolomide, topotecan, and cyclophosphamide.
What is the main goal of the study?
The main goal is to find out if these new medicine combinations are safe and how well they work to control the cancer.
Will I have many appointments?
Yes, taking part will involve regular visits for tests, scans, and to check for any side effects.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point, and your decision will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.