Study on Atezolizumab with Chemotherapy for Children with Relapsed or Hard-to-Treat Solid Tumors

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04796012

Provider View

This clinical trial is testing a new combination of drugs, including atezolizumab and chemotherapy, to see if it can help children with solid tumors that have returned or are not responding to treatment. The study will first check if the treatment is safe and then see how well it works, especially for a type of cancer called rhabdomyosarcoma.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment combination for children with solid tumors that have come back or are not responding to other treatments. The treatment includes a mix of drugs: vincristine, irinotecan, temozolomide, and atezolizumab. The study will first focus on whether this combination can be safely given to children. If it is safe, the study will then look at how well it works, particularly for rhabdomyosarcoma, a specific type of cancer.

Description

This study is divided into two parts. In the first part, researchers will test if the combination of atezolizumab with chemotherapy drugs vincristine, irinotecan, and temozolomide can be safely given to children with relapsed or hard-to-treat solid tumors. This part will include 6 children, and the treatment will be considered safe if no more than 2 children experience serious side effects. If the treatment is safe, the second part of the study will focus on children with rhabdomyosarcoma, a type of cancer. This part will include 17 children, and researchers will look at how well the treatment works in shrinking tumors and how long the effects last. The study will also measure how long children remain free from cancer progression. Children in the first part of the study who have rhabdomyosarcoma will also be included in the second part. The study aims to find out if this new combination of drugs can help children with these challenging cancers.

Eligibility Criteria

Inclusion Criteria

  • Must have a solid tumor that has come back or is not responding to previous treatments.
  • Must be between 6 months and 30 years old.
  • Must be able to follow the study procedures.
  • Must have a specific type of cancer called rhabdomyosarcoma for the second part of the study.
  • Must have a tumor that can be measured by scans.
  • Must provide a sample of the tumor for testing.
  • Must have good organ and bone marrow function based on specific blood tests.
  • Must not have HIV or hepatitis B.
  • Women who can have children must agree to use birth control during the study and for 5 months after.
  • Men must agree to use birth control and not donate sperm during the study and for 5 months after.

Exclusion Criteria

  • Cannot be pregnant or breastfeeding.
  • Cannot have certain autoimmune diseases or immune deficiencies.
  • Cannot have uncontrolled high calcium levels or fluid buildup in the body.
  • Cannot have uncontrolled pain or serious lung or heart conditions.
  • Cannot have had certain treatments or surgeries recently.
  • Cannot have active infections like tuberculosis or hepatitis C.
  • Cannot have allergies to the study drugs.

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