What side effects are associated with this type of intervention?

Common treatments for brain tumors, including chemotherapy, radiotherapy, and immunotherapy, have various side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased risk of infections due to lowered blood cell counts. Radiotherapy may lead to fatigue, skin reactions, and potential cognitive decline, especially in younger patients. Immunotherapy, such as vaccines designed to stimulate an immune response against glioma cells, can cause injection site reactions, flu-like symptoms, and in some cases, more severe immune-related adverse effects like inflammation of organs. These side effects vary based on the specific treatment regimen and patient characteristics.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including immunotherapies that stimulate the immune response against glioma cells. One notable example is the use of Tumor Treating Fields (TTF) in combination with temozolomide for glioblastoma, which has shown efficacy in prolonging survival. Additionally, checkpoint inhibitors like pembrolizumab and nivolumab have been explored for their potential in treating recurrent glioblastoma, although their benefits have been limited. While specific neoadjuvant vaccines for gliomas are still under investigation, these immunotherapies represent significant advancements in leveraging the immune system to combat brain tumors.

What other types of research exist?

Promising novel alternatives to neoadjuvant vaccines for brain tumor patients include: 1) Bevacizumab, an antiangiogenic therapy, which has shown efficacy in treating vestibular schwannomas and spinal ependymomas in NF2-related schwannomatosis. 2) Everolimus, an mTORC1 inhibitor, which has been effective in treating progressive vestibular schwannomas and meningiomas. 3) Ivosidenib, a mutant-IDH1 inhibitor, which has shown promise in clinical trials for IDH1-mutant gliomas. 4) Vorasidenib, a dual mutant-IDH1/2 inhibitor, currently in phase III testing for IDH1/2-mutant gliomas.

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Glioma Vaccine for Brain Tumor

Phase 1

Waitlist Available

Led By Hideho Okada, MD, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

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

Must have

Patients must be off corticosteroid for at least for 2 weeks before the first neoadjuvant vaccine and for at least 2 weeks prior to the first adjuvant vaccine

Hepatic: Total bilirubin ≤1.5 x upper limit of normal (ULN) and serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase (ALT)) ≤ 2.5 x upper limit of normal (ULN)

Must not have

History of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, transplant immunosuppression)

History or clinical suspicion of neurofibromatosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a vaccine given before surgery to help the immune system fight brain tumors in adults with tumors that are at high risk of becoming more aggressive. These tumors are at high risk of becoming more aggressive, and current treatments often fail. The vaccine aims to boost the body's natural defenses to better recognize and attack the tumor cells. This experimental treatment is being tested in several stages for its effectiveness against aggressive brain tumors.

Who is the study for?

Adults with a type of brain tumor called WHO grade II glioma, which needs surgery, can join this trial. They should be in good physical shape (Karnofsky performance status ≥ 70%), have normal organ function, and no recent chemotherapy or radiation therapy. People with serious autoimmune diseases, immune system disorders, current pregnancy or breastfeeding are not eligible.

What is being tested?

The study is testing two vaccine treatments: GBM6-AD and poly-ICLC given before and after brain surgery versus only after surgery to see if they're safe and can boost the body's immune response against the tumor.

What are the potential side effects?

Possible side effects may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue, headache, muscle pain. There might also be risks related to how the vaccines affect the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I haven't taken corticosteroids for at least 2 weeks before my vaccine.

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My liver tests for bilirubin and ALT are within normal limits.

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I am 18 years old or older.

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I have a type of brain tumor called grade II glioma that has been or will be confirmed by surgery.

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I have had surgery to remove a tumor weighing at least 500 mg.

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My kidney function is normal, based on creatinine tests.

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

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My brain tumor is likely a grade II glioma and needs surgery.

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My blood tests show enough white blood cells, platelets, and hemoglobin.

Exclusion Criteria

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

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I have a history of immune system issues, like autoimmune diseases or AIDS.

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I have or might have neurofibromatosis.

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I do not have conditions like AIDS, MS, uncontrolled diabetes, or renal failure.

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I am currently on medication that suppresses my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ minimum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~minimum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and minimum of 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Measurement of vaccine-induced immune response in the resected tumor

Number of Regimen Limiting Toxicity (RLT)

Secondary study objectives

Magnitude of response of CD4+ and CD8+ T-cell responses against the GM6-AD lysate in pre- and post-vaccine PBMC using IFN-γ-ELISPOT

Objective response rate (ORR)

Overall survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Vaccines before and after surgeryExperimental Treatment1 Intervention

GBM6-AD lysate protein 1 mg and poly-ICLC 1.4 mg administered as one formulation every week leading up to standard-of-care surgery to remove the WHO grade II glioma (Days -23±2, -16±2, -9±2 and 24-48 hours prior to scheduled surgery), every 3 weeks after surgery (Weeks A1, A4, A7, A10, A13, A16; defining Week A1 as the first post-surgery vaccine), and two booster vaccines (Weeks A32 and A48).

Group II: Vaccines after surgery onlyActive Control1 Intervention

GBM6-AD lysate protein 1 mg and poly-ICLC 1.4 mg administered as one formulation every 3 weeks after standard-of-care surgery to remove the WHO grade II glioma only (Weeks A1, A4, A7, A10, A13, A16; defining Week A1 as the first post-surgery vaccine) and two booster vaccines (Weeks A32 and A48). Patients will not receive vaccines before surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GBM6-AD and poly-ICLC before and after surgery

2016

Completed Phase 1

~30

0 / 13Eligibility 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

Common treatments for brain tumors include radiation therapy, chemotherapy, and immunotherapy. Radiation therapy works by damaging the DNA of cancer cells, leading to cell death. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells. Immunotherapy, such as the neoadjuvant vaccine being studied, stimulates the body's immune system to recognize and attack glioma cells. Understanding these mechanisms is crucial for brain tumor patients as it helps in selecting the most appropriate treatment, managing expectations, and potentially improving outcomes by targeting the tumor more effectively.