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.

Contact:

NCT Number:

Protocol:

AAAR5300

Study Status:

Active/Enrolling

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of a new vaccine, VBI-1901, and to know more about it's ability to boost the response of the immune system against Cytomegalovirus. The reason for testing this vaccine in people with a brain tumor is that it might one day be used to boost the ability of the immune system to fight a certain type of brain tumor. This type of treatment for brain tumors is called immunotherapy.

Are you Eligible? (Inclusion Criteria)

  • Participants must:
  • 1. Be 18 - 70 years of age
  • 2. Have histologically confirmed WHO grade IV glioblastoma
  • 3. Have unequivocal evidence of a tumor recurrence (any number of
  • recurrences) or progression after an initial treatment regimen (prior to
  • enrollment on this study)
  • 4. Have recovered from the effects of surgery

Specialty Area(s)

Principal Investigator

Profile Headshot
  • Chief, Division of Neuro-Oncology
  • Associate Director for Clinical Trials, Herbert Irving Comprehensive Cancer Center
  • Associate Dean of Clinical Research Compliance, Vagelos College of Physicians & Surgeons, Columbia University
  • Scientific Director, Network Capacity Resource, Irving Institute for Clinical & Translational Research

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032