Spots Global Cancer Trial Database for Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
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Trial Identification
Brief Title: Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
Official Title: 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
Study ID: NCT03382977
Conditions
Study Description
Brief 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).
Detailed Description: This is a three-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects and comparison with standard of care (SOC) treatment. Subjects in groups receiving VBI-1901 vaccination will continue to receive vaccine every 4 weeks until tumor progression per immunotherapy Response Assessment for Neuro-Oncology (iRANO)/Response Assessment for Neuro-Oncology (RANO) criteria.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Providence - Swedish Medical Center, Seattle, Washington, United States
Contact Details
Name: Francisco Diaz-Mitoma, MD
Affiliation: Variation Biotechnologies Inc.
Role: STUDY_DIRECTOR
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