Study on the Safety and Effectiveness of Cyclophosphamide, Sorafenib, Bevacizumab, and Atezolizumab in Children with Solid Tumors

Sponsor: St. Jude Children's Research Hospital

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05468359

Provider View

This clinical trial is testing a combination of medications to see if they are safe and effective for treating children and young adults with solid tumors that have returned or are not responding to treatment. The study involves using a mix of chemotherapy and immunotherapy drugs.

Patient Parameters

Program Overview

This study is divided into two parts. The first part focuses on ensuring the safety of a combination of drugs—cyclophosphamide, sorafenib, bevacizumab, and atezolizumab—in children and young adults with solid tumors that have come back or are not responding to treatment. The second part evaluates how well this combination works in treating specific types of cancer, like liver cancer and other rare solid tumors. The study aims to find out if this treatment can help shrink tumors and improve the immune response against cancer.

Description

In this study, researchers are testing a combination of drugs to treat children and young adults with solid tumors that have returned or are not responding to treatment. The treatment includes a mix of chemotherapy and immunotherapy drugs: cyclophosphamide, sorafenib, bevacizumab, and atezolizumab.

The study is divided into two parts:

  • Part 1: Focuses on the safety of the drug combination. Researchers will monitor how the body handles the drugs and adjust doses to find the safest and most effective levels. They will also look at how the treatment affects immune cells in the tumors.

  • Part 2: Evaluates how well the treatment works in shrinking tumors, especially in liver cancer and other rare solid tumors. Researchers will assess the response of the tumors to the treatment and any changes in the immune system.

Throughout the study, participants will undergo various tests and procedures to monitor their health and the effects of the treatment. The study also explores the possibility of using imaging techniques to track changes in the tumors and the immune response.

Eligibility Criteria

Inclusion Criteria

  • Must be under 30 years old.
  • Willing to participate in a related study on solid tumors.
  • Have a solid tumor that has returned or is not responding to treatment and can be biopsied.
  • Have a specific type of cancer, such as liver cancer or other rare solid tumors, that can be biopsied.
  • Be in good enough health to participate, with a performance score indicating they can perform daily activities.
  • Have tumors that cannot be surgically removed and can be measured or evaluated.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • Be willing to use effective birth control during the study and for at least five months after the last dose of treatment.
  • Have recovered from any previous cancer treatments before starting the study.
  • Have a life expectancy of at least eight weeks.

Exclusion Criteria

  • Pregnant or breastfeeding.
  • Currently taking other experimental drugs.
  • Unable or unwilling to follow the study's safety monitoring requirements.
  • Tumor cannot be safely biopsied.
  • Unable or unwilling to provide informed consent.
  • Have a non-healing wound or recent major surgery.
  • Have had a blood clot in the last three months or have a known blood clotting disorder.

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