Study on the Safety and Effectiveness of Ribociclib with Topotecan and Temozolomide in Children with Relapsed or Hard-to-Treat Neuroblastoma and Other Solid Tumors

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05429502

Provider View

This clinical trial is testing a combination of three drugs—Ribociclib, Topotecan, and Temozolomide—to see if they are safe and effective in treating children with neuroblastoma and other solid tumors that have returned or are difficult to treat.

Patient Parameters

Program Overview

The study aims to find out if a combination of three drugs—Ribociclib, Topotecan, and Temozolomide—can help treat children with neuroblastoma and other solid tumors that have come back or are hard to treat. The trial is divided into two phases. Phase I will determine the safest dose of the drug combination, while Phase II will test how well the treatment works in children with neuroblastoma.

Description

This study is divided into two main parts: Phase I and Phase II.

In Phase I, researchers will first find the safest dose of the drug combination (Ribociclib, Topotecan, and Temozolomide) for children. This part is called dose finding. After finding the right dose, the study will expand to include more children with different types of tumors to see how well the treatment works and to confirm its safety.

In Phase II, the study will focus on children with neuroblastoma to see if the treatment can effectively control the disease. This phase will be a double-blind, randomized trial, meaning neither the participants nor the researchers will know who is receiving the actual treatment or a placebo.

The study will include children aged 12 months to 21 years who have specific types of solid tumors that have not responded to standard treatments. Participants will need to meet certain health criteria to join the study, and they will be closely monitored for any side effects and the effectiveness of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Children aged 12 months to 21 years with specific types of solid tumors that have returned or are hard to treat.
  • Must have a confirmed diagnosis of neuroblastoma, medulloblastoma, high-grade glioma, malignant rhabdoid tumors, or rhabdomyosarcoma.
  • Must be able to understand and sign a consent form, or have a guardian who can do so.
  • Must have a life expectancy of at least 12 weeks.
  • Must have adequate bone marrow, liver, kidney, and heart function.
  • Females who are sexually active must use effective birth control during and for 6 months after treatment.
  • Males who are sexually active must use condoms during and for 6 months after treatment.

Exclusion Criteria

  • Allergic to any of the study drugs.
  • Not fully recovered from previous cancer treatments.
  • Have severe or uncontrolled medical conditions that could interfere with the study.
  • Have significant heart problems or are taking medications that affect heart rhythm.
  • Have taken certain medications or supplements that could interfere with the study drugs.
  • Have received live vaccines within 4 weeks before the study.
  • Have participated in another clinical trial within 30 days.
  • Have had previous treatment with a CDK4/6 inhibitor.
  • Have had major surgery within 2 weeks before the study.
  • Are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.

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