RecruitingPhase 1Phase 2NCT03382977

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects


Sponsor

VBI Vaccines Inc.

Enrollment

98 participants

Start Date

Dec 6, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new experimental vaccine called VBI-1901 for patients with a type of aggressive brain cancer called glioblastoma (GBM) that has come back after previous treatment, to find the safest and most effective dose and see if it can help slow the cancer's growth. **You may be eligible if...** - You are between 18 and 70 years old - Your brain cancer has been confirmed as grade IV glioblastoma (GBM) by tissue testing - Your tumor has grown back or progressed after receiving initial treatment, which must have included surgery and radiation (with or without chemotherapy) - An MRI of your brain has been done within 30 days before starting the study - Your overall health and organ function meet the required levels **You may NOT be eligible if...** - You have not previously received standard treatment (surgery plus radiation) - Your organ function or blood counts do not meet the required levels - You have other significant health conditions that make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALVBI-1901

The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.

DRUGCarmustine

Treatment with carmustine intravenously at a dose of 150 mg/m² on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.

DRUGLomustine

Treatment with lomustine given orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg) on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.


Locations(12)

University of California, Irvine

Irvine, California, United States

University of California, San Diego

La Jolla, California, United States

University of California, Los Angeles Neuro-Oncology Program

Los Angeles, California, United States

Stanford

Stanford, California, United States

Miami Cancer Institute

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

The Valley Hospital - Neurosurgeons of New Jersey

Ridgewood, New Jersey, United States

The Neurological Institute of New York Columbia University Medical Center

New York, New York, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Providence - Swedish Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03382977


Related Trials