Phase 1 Study of A Dendritic Cell Vaccine for High-grade Glioma and Glioblastoma
Researchers at the University of Miami in Florida are evaluating whether a partially matured dendritic cell vaccine is safe and effective for patients with glioma or glioblastoma.
Title: Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects1
Principal Investigators: Macarena De La Fuente, MD, University of Miami
Description: For this non-randomized, phase 1 trial, researchers at the University of Miami in Florida are evaluating whether a partially matured dendritic cell vaccine is safe and effective for patients with glioma or glioblastoma.
This study has 2 arms, 1 of which is a pilot arm and the other an expansion cohort. The treatment plan is identical for both.
Participants will undergo leukapheresis post-surgery followed by the dendritic cell vaccine, which will be administered once per week for 4 weeks in a dose-escalation scheme.
Post-vaccine, participants will receive up “to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.”
All participants will self-apply imiquimod before and after vaccine or lysate treatments.
The primary outcome is rate of adverse events; secondary outcomes include overall survival, progression-free survival, and measurement of immune response.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01808820.
Status: This study is open and recruiting patients as of July 21, 2017.
This study is sponsored by Edward Ziga, University of Miami.
- Clinicaltrials.gov. Dendritic cell (DC) vaccine for malignant glioma and glioblastoma. NCT01808820. https://clinicaltrials.gov/ct2/show/NCT01808820. Accessed July 21, 2017.