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Cancer Vaccine
Personalized DNA Vaccine for Pediatric Brain Tumor
Phase 1
Waitlist Available
Led By Karen M Gauvain, M.D., MSPH
Research Sponsored by Washington University School of Medicine
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 2 years
Awards & highlights
Study Summary
This trial is investigating whether a personalized DNA vaccine is safe and effective for people with brain tumors that have returned or are resistant to treatment.
Who is the study for?
This trial is for young people aged 12-39 with recurrent or resistant pediatric brain tumors. They must have had standard care for their tumor, tissue available for sequencing, and be able to consent. Excluded are those recently vaccinated (except COVID-19), pregnant/breastfeeding individuals, certain medical conditions, recent other immunotherapies or investigational agents, allergies to vaccines, uncontrolled illnesses/infections, immunodeficiency disorders/autoimmune conditions on therapy.Check my eligibility
What is being tested?
The study tests the safety and feasibility of a personalized DNA vaccine designed based on each patient's unique tumor characteristics using Ichor TDS-IM v2.0 after a blood draw. The goal is to see if this approach can help treat children and young adults whose brain tumors have not responded well to previous treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site due to the vaccine or electroporation process such as pain or swelling, general symptoms like fever or fatigue from immune response activation; specific risks will depend on individual patient factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of adjuvant personalized neoantigen DNA vaccine as measured the number of participants that had a neoantigen-specific DNA vaccine generated
Safety and tolerability of adjuvant personalized neoantigen DNA vaccine as measured by the number of grade 3 and 4 adverse events
Secondary outcome measures
Median Overall Survival
Median Progression Free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Personalized neoantigen DNA vaccineExperimental Treatment3 Interventions
Patients will receive the vaccine monthly (+/- 3 days) for 6 doses as a priming phase followed by booster injections quarterly Q3mo thereafter. If sufficient quantities of vaccine are available, vaccination may continue until development of intolerance or disease progression in the case of fatal high grade neoplasms or for up to one year. Additionally, patients with non-fatal tumors who complete one year of vaccinations and have stable disease at the completion of treatment will be given the option of resuming vaccinations if they develop subsequent progression.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peripheral blood draw
2017
Completed Phase 2
~60
Find a Location
Who is running the clinical trial?
Children's Discovery InstituteUNKNOWN
4 Previous Clinical Trials
468 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,702 Total Patients Enrolled
Karen M Gauvain, M.D., MSPHPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe illnesses that would stop me from following the study's requirements.My screening did not identify any targetable cancer markers.I haven't had cancer, except for certain types, in the last 3 years.I don't have severe brain pressure, uncontrolled seizures, or need immediate brain treatment.I do not have an infection needing treatment or a fever over 38.1˚C.I haven't received a live vaccine in the last 30 days, except for the COVID-19 vaccine if it's not live.I don't have significant heart, lung, liver, kidney, or blood disorders.I do not have any ongoing or chronic neurological conditions, except for a one-time fever-related seizure in childhood.I am taking Bevacizumab to control swelling in my brain and reduce my need for high doses of steroids.I can care for myself but may need occasional help.My blood counts and organ functions are within normal ranges.I have HIV but my CD4+ T-cell count is above 350 and I haven't had a major infection in the last year.I have fainted within the last year.I have received standard treatments for my recurrent or hard-to-treat pediatric brain tumor.Any side effects from my previous treatments have mostly gone away.I have tissue available for testing from a previous or upcoming surgery.I can understand and am willing to sign the consent form, or I have a guardian who can.My vaccine is custom-made for my cancer treatment.I am on low-dose steroids or use them topically/inhaled, and not more than 4mg daily if for vaccination.My thigh's midpoint circumference is less than 35 cm.I am aged 12-25 and have a recurring or resistant pediatric brain tumor.I have an immune system disorder or take medicine that affects my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Personalized neoantigen DNA vaccine
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.
Are there further opportunities for individuals to take part in this trial?
"This clinical research is not currently open for enrollment, as seen on the official records of clinicaltrials.gov which states that this protocol was first posted in January 31st 2023 and last updated in November 15th 2022. Nevertheless, there are 1,400 additional studies actively recruiting at present."
Answered by AI
What are the potential risks associated with personalized neoantigen DNA vaccine treatments?
"Limited evidence suggests the safety of this personalized neoantigen DNA vaccine, leading us to rate it a 1 on our scale of 1-3."
Answered by AI
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