This clinical trial is focused on studying the treatment of relapsed or refractory neuroblastoma and other solid tumors in children and young adults aged 12 months to 21 years. Neuroblastoma is a type of cancer that forms in certain types of nerve tissue. The study will use a combination of medications, including ribociclib (also known by its code name LEE011), temozolomide, and topotecan hydrochloride. These medications are being tested together to see if they can effectively treat these types of cancers.
The purpose of the study is to assess the safety and effectiveness of this combination of drugs. The study is divided into two phases. In the first phase, researchers will determine the best dose of ribociclib to use with the other medications. In the second phase, the study will further evaluate how well this combination works in treating neuroblastoma compared to a placebo. Participants will receive the medications either orally or through intravenous infusion, depending on the specific drug.
Throughout the study, participants will be closely monitored for any side effects and to see how their tumors respond to the treatment. The study aims to find the most effective and safe way to use these medications together to help treat these challenging cancers in young patients. The trial is expected to continue until 2029, allowing researchers to gather comprehensive data on the treatment’s impact.



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