What side effects are associated with this type of intervention?

Common treatments for malignant glioma, especially those involving immune system stimulation against tumor antigens like the P30-EPS vaccine, often include side effects such as injection site reactions, flu-like symptoms, and fatigue. More broadly, treatments like chemotherapy and radiation can cause nausea, vomiting, hair loss, and cognitive changes. Immune checkpoint inhibitors, another form of immunotherapy, can lead to immune-related adverse events such as colitis, pneumonitis, and thyroid dysfunction.

What prior FDA approvals exist?

The FDA has approved several treatments for malignant glioma, including temozolomide and bevacizumab. However, in terms of immunotherapy, there are limited FDA-approved options specifically targeting tumor antigens in glioma. Treatments like pembrolizumab, an immune checkpoint inhibitor, have shown promise in other cancers and are being explored in glioma. The P30-EPS vaccine trial represents an innovative approach by stimulating the immune system against specific tumor antigens, similar to other investigational immunotherapies in clinical trials.

What other types of research exist?

Promising novel alternatives to the P30-EPS vaccine for malignant glioma patients include: 1) CAR T-cell therapies targeting specific glioma antigens, 2) Immune checkpoint inhibitors such as nivolumab and pembrolizumab, 3) Oncolytic virus therapies that selectively infect and kill tumor cells while stimulating an immune response, and 4) Personalized neoantigen vaccines tailored to the unique mutations of an individual's tumor.

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Cancer Vaccine

Peptide Vaccine for Brain Cancer (ETAPA I Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for Malignant Glioma include surgery, radiation therapy, and chemotherapy, often with temozolomide. Recently, immunotherapy approaches, such as the P30-EPS vaccine, have gained attention. These vaccines work by stimulating the patient's immune system to recognize and attack tumor-associated antigens, such as EphA2, CMV pp65, and survivin. This is crucial for Malignant Glioma patients because these tumors are highly aggressive and often resistant to conventional therapies. By harnessing the body's immune system, these treatments aim to provide a more targeted and potentially effective approach to controlling tumor growth and improving patient outcomes.

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

Must not have

Patients who received previous inguinal lymph node dissection or had radiosurgery, brachytherapy, or radiolabeled monoclonal antibodies to treat a CNS tumor will be excluded.

Patients are not permitted to have had any other conventional therapeutic intervention other than surgery, steroids, and standard of care chemoradiation prior to enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new vaccine called P30-EPS in patients with a specific type of aggressive brain cancer. The vaccine helps the immune system recognize and attack cancer cells by using three special proteins.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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I am 18 years old or older.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had specific surgeries or radiation treatments for a brain tumor.

Select...

I have only had surgery, steroids, or standard chemoradiation before joining.

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I do not have severe health issues that could interfere with the treatment.

Select...

My cancer has spread to my brainstem, cerebellum, spinal cord, or I have multiple tumors or leptomeningeal disease.

Select...

My brain tumor has spread outside the area that was previously treated with radiation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of patients who experience dose-limiting toxicity

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Malignant Glioma include surgery, radiation therapy, and chemotherapy, often with temozolomide. Recently, immunotherapy approaches, such as the P30-EPS vaccine, have gained attention. These vaccines work by stimulating the patient's immune system to recognize and attack tumor-associated antigens, such as EphA2, CMV pp65, and survivin. This is crucial for Malignant Glioma patients because these tumors are highly aggressive and often resistant to conventional therapies. By harnessing the body's immune system, these treatments aim to provide a more targeted and potentially effective approach to controlling tumor growth and improving patient outcomes.