← Back to Search

Cancer Vaccine

Peptide Vaccine for Brain Cancer (ETAPA I Trial)

Q: Has the FDA granted its seal of approval for Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine?

<p>Tumor Associated Antigen Peptide <a href="https://www.withpower.com/clinical-trials/vaccine">Vaccine</a> P30-EPS Vaccine has been assigned a safety score of 1 due to the lack of available data concerning its efficacy and safety in this early stage clinical trial.</p>

Q: Could you please provide information about patient eligibility for this clinical trial?

<p>As per the clinicaltrials.gov entry, this research endeavour is no longer recruiting participants. Initially posted on November 1st 2022 and last updated on August 17th 2022, it has already ceased admitting new patients. However, 356 other trials are currently enrolling volunteers at present.</p>

Phase 1

Recruiting

Research Sponsored by Mustafa Khasraw, MBChB, MD, FRCP, FRACP

Eligibility Criteria Checklist

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

Must have

Newly diagnosed Isocitrate dehydrogenase (IDH) wild type (CARIS result), MGMT promoter unmethylated (CARIS result) WHO grade IV glioma (e.g., glioblastoma (GBM) or high grade glioma with molecular features of GBM) with definitive resection prior to enrollment, residual radiographic contrast enhancement on immediate post-surgical computed tomography (CT), or magnetic resonance imaging (MRI) of <1 cm in maximal diameter in any plane.

Age ≥ 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

ETAPA I Trial Summary

This trial will test a new vaccine for brain cancer.

Who is the study for?

Adults over 18 with a specific type of brain tumor called WHO grade IV malignant glioma that hasn't been treated yet. They must have had surgery to remove the tumor, be HLA A*0201 positive, and not pregnant or breastfeeding. Participants need good blood counts and organ function, and agree to use effective contraception.Check my eligibility

What is being tested?

The trial is testing a new vaccine made from peptides linked to proteins found in tumors (P30-EPS) for patients with a certain genetic makeup. It's an early-phase study to see if this vaccine can help treat brain tumors without previous treatment.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions related to vaccines such as soreness at the injection site, fever, fatigue, allergic reactions or autoimmune responses due to immune system activation.

ETAPA I Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have a specific type of brain tumor (grade IV glioma) with certain genetic features and had surgery to remove it.

Select...

I am 18 years old or older.

Select...

My genetic test shows I am HLA A*0201 positive.

Select...

I have been tested for CMV, regardless of the result.

Select...

I am mostly able to care for myself and carry out daily activities.

ETAPA I Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percentage of patients who experience dose-limiting toxicity

Secondary outcome measures

Change in mean fold increase in EphA2- or survivin- specific T cells; Time Frame: Days 1, 22, 84

Change in mean fold increase in pp56-specific T cells; Time Frame: Day 1, 22, 84

Median progression-free survival

+1 more

ETAPA I Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor Associated Antigen Peptide Vaccine in Combination with HiltonolExperimental Treatment2 Interventions

The study vaccine is comprised of three different peptides (small proteins) mixed with Hiltonol®. The three peptides that make up the study vaccine are called pp65, EphA2, and survivin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hiltonol

2015

Completed Phase 2

~110

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mustafa Khasraw, MBChB, MD, FRCP, FRACPLead Sponsor

3 Previous Clinical Trials

85 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,096 Total Patients Enrolled

Media Library

P30-EPS Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05283109 — Phase 1

Malignant Glioma Research Study Groups: Tumor Associated Antigen Peptide Vaccine in Combination with Hiltonol

Malignant Glioma Clinical Trial 2023: P30-EPS Vaccine Highlights & Side Effects. Trial Name: NCT05283109 — Phase 1

P30-EPS Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283109 — Phase 1

Frequently Asked Questions

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

Has the FDA granted its seal of approval for Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine?

"Tumor Associated Antigen Peptide Vaccine P30-EPS Vaccine has been assigned a safety score of 1 due to the lack of available data concerning its efficacy and safety in this early stage clinical trial."

Answered by AI

Could you please provide information about patient eligibility for this clinical trial?

"As per the clinicaltrials.gov entry, this research endeavour is no longer recruiting participants. Initially posted on November 1st 2022 and last updated on August 17th 2022, it has already ceased admitting new patients. However, 356 other trials are currently enrolling volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM

Mustafa Khasraw, MBChB, MD, FRCP, FRACP 2023. "ETAPA I: Peptide-based Tumor Associated Antigen Vaccine in GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05283109.