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Glioma Vaccine for Brain Tumor

Phase 1

Waitlist Available

Led By Jennie Taylor, MD

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up minimum of 2 years

Awards & highlights

Study Summary

This trial is testing a new vaccine for brain cancer. The goal is to see if it is safe and if it increases the level of a certain type of immune cell in the tumor.

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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Measurement of vaccine-induced immune response in the resected tumor

Number of Regimen Limiting Toxicity (RLT)

Secondary outcome measures

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

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.

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,527 Total Patients Enrolled

Jennie TaylorLead Sponsor

University of MinnesotaOTHER

1,379 Previous Clinical Trials

1,588,468 Total Patients Enrolled

Media Library

GBM6-AD and poly-ICLC before and after surgery 2023 Treatment Timeline for Medical Study. Trial Name: NCT02549833 — Phase 1

Frequently Asked Questions

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

Is this examination open to new participants?

"This clinical trial, initially posted on October 17th 2016 and last updated September 20th 2022 is not currently recruiting participants. Nonetheless, there are 391 other studies actively seeking patients at this time."

Answered by AI

What tangible results is this trial hoping to accomplish?

"This clinical trial's objective is to evaluate the Number of Regimen Limiting Toxins (RLT) over a certain period. Its secondary objectives include measuring Response rate of CD4+ and CD8+ T-cell responses against GM6-AD lysate in pre- and post-vaccine peripheral blood mononuclear cell (PBMC), using IFN-γ-ELISPOT, Objective response rate (ORR) according to low grade glioma RANO, as well as Magnitude of response of CD4+ and CD8+ T cells responding to GM6-AD lystate in pre"

Answered by AI

Does the combination of GBM6-AD and poly-ICLC pose any health risks to individuals before or after undergoing surgery?

"Taking safety into account, GBM6-AD and poly-ICLC are rated a 1 on the scale since this is only Phase I of the trial. This indicates that there is limited data available for both efficacy and cautionary measures."

Answered by AI

Recent research and studies

Journal of Clinical InvestigationJournal

Randomized Trial of Neoadjuvant Vaccination with Tumor-cell Lysate Induces T Cell Response in Low-grade Gliomas

Ogino, Hirokazu, Jennie W. Taylor, Takahide Nejo, David Gibson, Payal B. Watchmaker, Kaori Okada, Atsuro Saijo, et al.. 2022. “Randomized Trial of Neoadjuvant Vaccination with Tumor-cell Lysate Induces T Cell Response in Low-grade Gliomas”. Journal of Clinical Investigation. American Society for Clinical Investigation. doi:10.1172/jci151239.

Journal of Clinical InvestigationJournal

Randomized Trial of Neoadjuvant Vaccination with Tumor-cell Lysate Induces T Cell Response in Low-grade Gliomas

clinicaltrials.govStudy

Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma

Jennie Taylor 2016. "Neo-adjuvant Evaluation of Glioma Lysate Vaccines in WHO Grade II Glioma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02549833.

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