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Cancer Vaccine

Vaccine for Brain Tumor

Q: Has the FDA cleared HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC for use?

<p>While there is some safety data for the <a href="https://www.withpower.com/clinical-trials/experimental">Experimental</a>: HLA-A2 Restricted <a href="https://www.withpower.com/clinical-trials/glioma">Glioma</a> Antigen-Peptides with Poly-ICLC, it is only from a Phase 2 trial which means that there is no efficacy data. This gave it a score of 2.</p>

Q: Who does this research trial require as participants?

<p>This study is looking for 25 patients with <a href="https://www.withpower.com/clinical-trials/glioma">glioma</a> who are between the ages of 12 months and 21. In addition to meeting this age criteria, participants must also have a performance status of ≥ 70; (Karnofsky if > 16 years and Lansky if ≤ 16 years of age.), be free of systemic infection requiring IV <a href="https://www.withpower.com/clinical-trials/antibiotics">antibiotics</a> at the time of registration, off IV antibiotics for at least 7 days prior to registration., Tumor Type, Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not</p>

Phase 2

Recruiting

Led By Alberto Broniscer, MD

Research Sponsored by James Felker

Eligibility Criteria Checklist

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

Must have

HLA-A2 positive based on flow cytometry.

Patients must be ≥ 12 months and < 22 years of age at the time of HLA-A2 screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Study Summary

This trial will test a vaccine to treat children with brain tumors that have not responded to other treatments.

Who is the study for?

This trial is for children and young adults aged between 1 to less than 22 years with low-grade gliomas that have undergone at least two prior treatments, including chemotherapy or radiation. Participants must be HLA-A2 positive, stable on low-dose steroids or off steroids for a week, not pregnant, free of infections requiring IV antibiotics for seven days, and have good organ function.Check my eligibility

What is being tested?

The trial tests the safety and effectiveness of a vaccine combining glioma antigen peptides with an immune booster called Poly-ICLC in patients who are genetically compatible (HLA-A2+). It aims to see if this can stimulate the immune system against brain tumors without surgery.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills due to immune activation by Poly-ICLC. There might also be risks associated with stimulating the immune system which could affect normal tissues.

Eligibility Criteria

Inclusion Criteria

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

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My immune system marker, HLA-A2, is positive.

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I am between 12 months and 22 years old.

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My blood, liver, and kidney functions are within normal ranges.

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I am mostly active and can care for myself.

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I do not have any major heart, stomach, lung, or mental health issues.

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I have been on a low dose or no steroids for at least a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor shrinkage or stable disease

Trial Design

1Treatment groups

Experimental Treatment

Group I: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLCExperimental Treatment1 Intervention

All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

James FelkerLead Sponsor

2 Previous Clinical Trials

84 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,980 Total Patients Enrolled

Connor's CureOTHER

1 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02358187 — Phase 2

Low Grade Glioma Research Study Groups: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC

Low Grade Glioma Clinical Trial 2023: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC Highlights & Side Effects. Trial Name: NCT02358187 — Phase 2

HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02358187 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC for use?

"While there is some safety data for the Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC, it is only from a Phase 2 trial which means that there is no efficacy data. This gave it a score of 2."

Answered by AI

Who does this research trial require as participants?

"This study is looking for 25 patients with glioma who are between the ages of 12 months and 21. In addition to meeting this age criteria, participants must also have a performance status of ≥ 70; (Karnofsky if > 16 years and Lansky if ≤ 16 years of age.), be free of systemic infection requiring IV antibiotics at the time of registration, off IV antibiotics for at least 7 days prior to registration., Tumor Type, Unresectable low-grade gliomas that have received at least two chemotherapy/biologic regimens. Radiation therapy counts as a biologic regimen. Patients may not"

Answered by AI

Can patients sign up for this trial right now?

"That is correct, the clinical trial mentioned is still open and looking for volunteers. The listing was first posted on 1/1/2015 with the latest update being 10/23/2022. They are currently only searching for 25 more participants across 1 location."

Answered by AI

Is this experiment only testing on individuals who are over the age of 20 years old?

"Children aged one year to adolescents 21 years old are eligible for this study, which has 136 enrollees so far. There are 243 other studies ongoing with senior citizens 65+."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Vaccine Trial for Low Grade Gliomas

James Felker 2015. "A Vaccine Trial for Low Grade Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02358187.