RecruitingPhase 1Phase 2NCT04796012

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors

VITAS: Atezolizumab in Combination With Chemotherapy for Pediatric Relapsed/Refractory Solid Tumors: An Open-label, Phase II, Single-arm, Multi-center Trial


Sponsor

University of Texas Southwestern Medical Center

Enrollment

23 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.


Eligibility

Min Age: 6 MonthsMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This pediatric trial is testing atezolizumab — an immunotherapy drug that helps the immune system recognize and kill cancer — combined with standard chemotherapy in children and young people with solid tumors that have come back or stopped responding to prior treatment. The study covers a range of tumor types and aims to find safe, effective combinations. **You may be eligible if...** - You are a child or adolescent with a solid tumor that has relapsed or is refractory (not responding) after at least one prior treatment - Your cancer is not Hodgkin or non-Hodgkin lymphoma - If you have brain tumors or brain metastases, they must meet specific safety criteria - You and your guardian are able to give signed informed consent **You may NOT be eligible if...** - You have Hodgkin or non-Hodgkin lymphoma - You have cancer affecting critical brain structures (brainstem, midbrain, pons, cerebellum) or near the optic nerve - You have a history of leptomeningeal disease (cancer in the fluid around the brain and spine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Feasibility and RMS Cohorts: Administered at 15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle

DRUGVincristine

Feasibility and RMS Cohorts: Administered at 1.5 mg/m\^2 (max 2 mg) IV on Day 1 of each 21-day cycle

DRUGIrinotecan

Feasibility and RMS Cohorts: Administered at 50 mg/m2 IV on Days 1-5 of each 21-day cycle

DRUGTemozolomide

Feasibility and RMS Cohorts: Administered at 100 mg/m\^2 (max 200 mg) IV or PO 1 hour before irinotecan injection on Days 1-5 if each 21-day cycle


Locations(7)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

Seattle Children's

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT04796012


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