Phase I Study of a Dendritic Cell Vaccine for Patients With Either Newly Diagnosed or Recurrent Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Astrocytoma
- Brain Tumor
- Glioblastoma
- Glioblastoma Multiforme
- Glioma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This phase I study for patients with either newly diagnosed or recurrent glioblastoma with minimal residual tumor utilizes a dendritic cell vaccine consisting of autologous dendritic cells that have been pulsed with a lysate derived from an allogeneic glioblastoma stem-like cell line cultured under ...
This phase I study for patients with either newly diagnosed or recurrent glioblastoma with minimal residual tumor utilizes a dendritic cell vaccine consisting of autologous dendritic cells that have been pulsed with a lysate derived from an allogeneic glioblastoma stem-like cell line cultured under neurosphere-forming conditions. Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the Induction phase beginning at the conclusion of radiation. Patients with recurrent glioblastoma will not receive treatment other than the investigative treatment, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab.
Tracking Information
- NCT #
- NCT02010606
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jethro Hu, MD Cedars-Sinai Medical Center