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Cancer Vaccine

Vaccine + Poly-ICLC for Pediatric Brain Cancer

Phase 1

Waitlist Available

Led By Alberto Broniscer, MD

Research Sponsored by Ian F. Pollack, M.D.

Eligibility Criteria Checklist

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

Must have

Stratum A: Newly diagnosed diffuse intrinsic pontine gliomas OR any biopsy proven high-grade glioma* involving the brainstem. Patients may not have received chemotherapy during or after radiation. (Note: Stratum A is closed to accrual.)

Stratum D: Non-brainstem high-grade gliomas* that have recurred following treatment. (Note: Stratum D is closed to accrual.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial will study whether a vaccine is safe and generates an immune response. If so, a larger study will be done to see if the vaccine is effective.

Who is the study for?

This trial is for children and young adults (1-21 years old) with specific types of brain tumors called pediatric gliomas. Participants must have stable health, not be pregnant, agree to birth control use, and meet certain criteria based on their tumor type and previous treatments. They should also have a good performance status and life expectancy of at least 8 weeks.Check my eligibility

What is being tested?

The study tests the safety and immune response to a vaccine made from glioma antigen peptides combined with Poly-ICLC in patients with pediatric gliomas. The goal is to determine if this approach warrants further investigation in larger clinical efficacy trials.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 or chills, fatigue, allergic responses, or other immune-related effects due to stimulation of the body's defense mechanisms.

Eligibility Criteria

Inclusion Criteria

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

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I have a new diagnosis of a specific brainstem tumor and haven't had chemotherapy during or after radiation.

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My high-grade glioma has come back after treatment.

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I have a new high-grade glioma and haven't had chemotherapy with my radiation.

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

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My diagnosis is GBM, AA, or gliosarcoma without any oligodendroglioma component.

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I am between 12 months and 22 years old.

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My kidney function is good based on tests.

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My blood and liver tests are within the required ranges.

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I have received radiation therapy to my brain and spine.

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I do not have any infections in my body.

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I am mostly independent and active.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ monitoring will continue as long as subject remains on study.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~monitoring will continue as long as subject remains on study.

This trial's timeline: 3 weeks for screening, Varies for treatment, and monitoring will continue as long as subject remains on study. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety: Tolerability during the first two vaccine courses as defined in the protocol.

Secondary outcome measures

Glioma-associated antigen-specific T-cell response

Trial Design

1Treatment groups

Experimental Treatment

Group I: HLA Restricted glioma antigen peptides plus Poly ICLCExperimental Treatment2 Interventions

All subjects will receive vaccine plus Poly ICLC will receive 9 injections ( once every 3 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Poly-ICLC

2016

Completed Phase 2

~240

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ian F. Pollack, M.D.Lead Sponsor

4 Previous Clinical Trials

72 Total Patients Enrolled

James FelkerLead Sponsor

2 Previous Clinical Trials

49 Total Patients Enrolled

Ellie Kavalieros FundUNKNOWN

Media Library

Pediatric Glioma Clinical Trial 2023: HLA-A2 restricted glioma antigen peptides vaccine Highlights & Side Effects. Trial Name: NCT01130077 — Phase 1

Frequently Asked Questions

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

Does the research extend to geriatric populations?

"The upper age limit for this research is set at 21 years old, whereas the lower cutoff point stands at 12 months of age."

Answered by AI

Has the FDA certified Poly-ICLC for medicinal use?

"Due to the preliminary nature of this trial, which has limited data supporting safety and efficacy, Poly-ICLC receieved a rating of 1 on our team's safety scale."

Answered by AI

Are there any criteria I must meet to qualify for this research?

"In order to be considered for this clinical trial, the patient must have glioma and fall between 12 months and 21 years of age. At present, 60 participants are being sought out."

Answered by AI

Is there currently an opportunity to participate in this research trial?

"According to clinicaltrials.gov, this medical experiment is not currently recruiting patients; the trial was initially posted on February 1st 2009 and edited most recently on October 23rd of 2022. However, 1314 other studies are actively seeking participants for their research projects."

Answered by AI

Recent research and studies

Journal of Neuro-OncologyJournal

Diffuse Intrinsic Pontine Glioma: A Reassessment

Robison, Nathan J., and Mark W. Kieran. 2014. “Diffuse Intrinsic Pontine Glioma: A Reassessment”. Journal of Neuro-oncology. Springer Science and Business Media LLC. doi:10.1007/s11060-014-1448-8.

Journal of Clinical OncologyJournal

Antigen-specific Immune Responses and Clinical Outcome After Vaccination with Glioma-associated Antigen Peptides and Polyinosinic-polycytidylic Acid Stabilized by Lysine and Carboxymethylcellulose in Children with Newly Diagnosed Malignant Brainstem and Nonbrainstem Gliomas

Pollack, Ian F., Regina I. Jakacki, Lisa H. Butterfield, Ronald L. Hamilton, Ashok Panigrahy, Douglas M. Potter, Angela K. Connelly, Sharon A. Dibridge, Theresa L. Whiteside, and Hideho Okada. 2014. “Antigen-specific Immune Responses and Clinical Outcome After Vaccination with Glioma-associated Antigen Peptides and Polyinosinic-polycytidylic Acid Stabilized by Lysine and Carboxymethylcellulose in Children with Newly Diagnosed Malignant Brainstem and Nonbrainstem Gliomas”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2013.54.0526.

clinicaltrials.govStudy

A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas

James Felker 2009. "A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction With Poly-ICLC in Pediatric Gliomas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01130077.