Phase 1 Study of A Dendritic Cell Vaccine for High-grade Glioma and Glioblastoma

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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.
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.

Reference

  1. Clinicaltrials.gov. Dendritic cell (DC) vaccine for malignant glioma and glioblastoma. NCT01808820. https://clinicaltrials.gov/ct2/show/NCT01808820. Accessed July 21, 2017.

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