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Cancer Vaccine
GVAX + Checkpoint Inhibitors for Neuroblastoma
Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vaccination
The number of participants with grade 4 toxicities
Secondary outcome measures
Overall Survival
Overall best response
Progression-free survival (PFS)
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
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,922 Total Patients Enrolled
10 Trials studying Neuroblastoma
3,954 Patients Enrolled for Neuroblastoma
Natalie B Collins, MD, PHDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not on high-dose steroids, except for adrenal insufficiency or as premedication.I, or my guardian, can understand and sign the consent form.I can do most activities but need help with some.I do not have any serious illnesses that are not under control.My liver is working well.I am HIV-positive and not on antiretroviral therapy.I am a teenager aged 13 to less than 16.I had cancer before but have been free of it for over 2 years.I have been treated with specific immune therapy drugs before.I have brain metastases.I am between 10 and 12 years old.My neuroblastoma has come back or didn't fully go away after treatment.My child has high-risk neuroblastoma as defined by the Children's Oncology Group.I am not pregnant or breastfeeding.I have had cancer other than neuroblastoma.I am scheduled for neuroblastoma surgery at Boston Children's Hospital.My neuroblastoma is confirmed high-risk by specific tests.I do not have trouble breathing when I am resting.I have had treatment for a non-spreading cancer like skin or in-situ bladder, cervical, or breast cancers.I have had or currently have lung inflammation treated with steroids.It has been over a week since my last biologic therapy dose.My lung function is within normal limits.I am between 2 and 6 years old.I last took monoclonal antibodies more than a week ago and have recovered from side effects.I have an active autoimmune disease needing treatment in the last year, except for vitiligo or resolved childhood asthma.I am between 1 and 2 years old.I am a child aged between 6 and 9 years old.My pancreas works well.I do not have severe side effects from treatment.It's been over 3 weeks since my last strong chemotherapy.I have recovered from side effects of my previous cancer treatments.My bilirubin levels are within the normal range for my age.My kidney function, based on my age and sex, is within the normal range.I am 16 or older with a specific health measurement.My kidneys work well enough to clear waste.It's been over 2 weeks since my small area radiation or over 12 weeks since my large area radiation.I had a stem cell transplant more than 6 weeks ago after intensive treatment.I have undergone 131I-MIBG therapy more than 6 weeks ago.My bone marrow is working well.I am older than 1 year.
Research Study Groups:
This trial has the following groups:- Group 1: Relapsed or Refractory High Risk Neuroblastoma
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the possible side effects of the GVAX vaccine?
"GVAX vaccine safety is estimated to be a 1 because this is only a Phase 1 trial. This limited data means that there is not much information currently available supporting the efficacy or safety of GVAX."
Answered by AI
What maladies does GVAX vaccine target?
"GVAX vaccine is a popular choice for anti-angiogenic therapy and has also been used to treat other conditions like malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
How many patients will be enrolled in this clinical trial?
"Yes, according to the latest information on clinicaltrials.gov, this particular trial is looking for 26 more patients to participate. The study was first posted on 1/29/2020 and has been updated as recently as 10/17/2022. There are presently 2 locations where the trial is being conducted."
Answered by AI
What is the historical efficacy of GVAX vaccine in clinical trials?
"Right now, there are 797 different ongoing clinical trials studying the GVAX vaccine. 86 of these trials have progressed to Phase 3 testing. The majority of the research being conducted on the GVAX vaccine is based in Pittsburgh, but there are 43380 total locations running active trials for this medication."
Answered by AI
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