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CAR T-cell Therapy

GD2 T-Cells + Chemotherapy for Neuroblastoma (VEGAS Trial)

Phase 1

Waitlist Available

Led By Cliona Rooney, PhD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Recovered from the acute toxic effects of all prior chemotherapy

Karnofsky/Lansky score of greater than or equal to 50

Must not have

Severe intercurrent infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the largest safe dose of GD2-T cells in combination with a varicella zoster vaccine and lymphodepleting chemotherapy. The side effects of the treatment will also be studied.

Who is the study for?

This trial is for patients with relapsed or refractory osteosarcoma or high-risk neuroblastoma that hasn't responded to standard treatments. Participants must have a certain level of physical fitness, adequate organ function, and not be pregnant. They should have had prior exposure to the varicella zoster virus (chickenpox) or been vaccinated against it.

What is being tested?

The study tests a combination therapy using GD2-T cells genetically modified to target cancer cells, alongside lymohodepleting chemotherapy and a varicella zoster vaccine. The goal is to determine the highest safe dose of these T cells and assess their effectiveness in treating advanced sarcomas and neuroblastoma.

What are the potential side effects?

Potential side effects may include reactions from the immune system such as inflammation, symptoms related to chemotherapy like nausea and fatigue, possible allergic reactions to murine proteins in the treatment components, and risks associated with gene transfer.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have recovered from side effects of my previous cancer treatments.

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I am able to live with some level of independence.

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I have had chickenpox or received the chickenpox vaccine.

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My osteosarcoma or neuroblastoma has returned or didn't respond to standard treatments.

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My T cells are modified to target my cancer effectively.

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My liver, kidney functions, and blood counts are within the required ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe ongoing infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of patients with dose limiting toxicity

Secondary study objectives

Amount of T cells in the blood after the infusions

Number of patients with a response to the T cells

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: GD2 T cells plus VZV vaccineExperimental Treatment4 Interventions

In this study we will be administering from 1 x 10\^6 to 1 x 10\^9 transduced autologous VZV-specific CTLs, derived from VZV-specific memory T cells, so there will be no risk of alloreactivity. 6.1.1 Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m2/day followed by Fludarabine 30 mg/m2/day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860