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Cancer Vaccine

GVAX + Checkpoint Inhibitors for Neuroblastoma

Phase 1

Waitlist Available

Led By Natalie B Collins, MD, PHD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

Lansky/Karnofsky performance status ≥50%

Age 13 to < 16 years Male: 1.5 Female: 1.4

Must not have

No systemic corticosteroid therapy, other than replacement therapy for adrenal insufficiency or transfusion premedication. Participants who are receiving or have received lympholytic steroid (>=40mg/m2 prednisone equivalent) therapy within 4 weeks of first anticipated vaccine administration are excluded, because high-dose steroid therapy is expected to significantly limit the ability of the immune system to respond to GVAX vaccination.

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying how well GVAX, given in combination with nivolumab and ipilimumab, works in treating patients with neuroblastoma.

Who is the study for?

This trial is for children over 1 year old with high-risk neuroblastoma, who can undergo surgery at Boston Children's Hospital. They must have recovered from previous cancer treatments and meet specific blood, liver, kidney, and lung function criteria. Pregnant women are excluded, as well as those with certain immune conditions or recent steroid therapy.

What is being tested?

The study tests a vaccine called GVAX made from the patient's own tumor cells combined with nivolumab and ipilimumab immunotherapies. It aims to treat neuroblastoma by helping the body's immune system recognize and fight cancer cells.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (autoimmune reactions), infusion-related reactions like fever or chills, fatigue, digestive issues such as diarrhea or nausea, skin rash or itching.

Eligibility Criteria

Inclusion Criteria

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

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I can do most activities but need help with some.

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I am a teenager aged 13 to less than 16.

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I am between 10 and 12 years old.

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My child has high-risk neuroblastoma as defined by the Children's Oncology Group.

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I am scheduled for neuroblastoma surgery at Boston Children's Hospital.

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My neuroblastoma is confirmed high-risk by specific tests.

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I do not have trouble breathing when I am resting.

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It has been over a week since my last biologic therapy dose.

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I am between 2 and 6 years old.

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I am between 1 and 2 years old.

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I am a child aged between 6 and 9 years old.

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I do not have severe side effects from treatment.

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My bilirubin levels are within the normal range for my age.

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I am 16 or older with a specific health measurement.

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My kidneys work well enough to clear waste.

Exclusion Criteria

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

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I am not on high-dose steroids, except for adrenal insufficiency or as premedication.

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I have had or currently have lung inflammation treated with steroids.

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I do not have any serious illnesses that are not under control.

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I am HIV-positive and not on antiretroviral therapy.

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I have been treated with specific immune therapy drugs before.

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I have brain metastases.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Vaccination

The number of participants with grade 4 toxicities

Secondary study objectives

Overall Survival

Overall best response

Progression-free survival (PFS)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: Relapsed or Refractory High Risk NeuroblastomaExperimental Treatment4 Interventions

Tissue Collection of Cancerous cells during primary or clinically indicated surgical resection. Manufacture and cryopreservation of vaccine. Treatment with vaccine, nivolumab and ipilimumab. * Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted. * Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days * Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days * Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Ipilimumab

FDA approved

0 / 22Eligibility criteria met