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Monoclonal Antibodies

Combination Chemotherapy for Pediatric Cancer

Phase 1 & 2

Recruiting

Led By Jessica Gartrell, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of cycle 2 (each cycle is 21 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of drugs as a possible treatment for children and young adults with solid tumors that have come back or have not responded to previous treatment.

Who is the study for?

This trial is for children and young adults under 30 with certain types of advanced solid tumors that can't be removed by surgery. They should have a specific level of organ function, not be on other investigational drugs, and must not be pregnant or breastfeeding. Participants need to have recovered from previous treatments and agree to birth control measures.

What is being tested?

The study tests the safety and effectiveness of combining IV atezolizumab with bevacizumab every three weeks, daily oral cyclophosphamide, and sorafenib adjusted based on blood levels in pediatric patients with relapsed or refractory solid tumors including liver cancer.

What are the potential side effects?

Possible side effects include immune-related reactions due to atezolizumab, high blood pressure from bevacizumab, bleeding issues from both drugs, liver problems from sorafenib, as well as nausea and hair loss commonly associated with cyclophosphamide.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of cycle 2 (each cycle is 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of cycle 2 (each cycle is 21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of cycle 2 (each cycle is 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PK measure of sorafenib

Sorafenib

Part 1: Recommended phase 2 doses (RP2Ds)

+2 more

Secondary study objectives

Event Free Survival

Overall Survival

Part 1:Response rate of relapsed or refractory solid tumors

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment4 Interventions

All participants will receive Atezolizumab, Bevacizumab,Sorafenib and cyclophosphamide until maximum tolerated dose is reached.Tolerability will be defined after completion of Course 1. Part 2 will begin once the recommended phase 2 dose (RP2D) is determined.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2016

Completed Phase 3

~5860

Sorafenib

2014

Completed Phase 3

~2340