NCT01808820

Dendritic Cell (DC) Vaccine for Malignant Glioma and Glioblastoma

Dendritic Cell Vaccine For Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Macarena De La Fuente, MD · Academic / Other
• Sex: All
• Age: 13 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate an investigational vaccine using patent-derived dendritic cells (DC) to treat malignant glioma or glioblastoma.

Conditions

• Malignant Glioma
• Glioblastoma Multiforme
• Anaplastic Astrocytoma
• High Grade Glioma

Interventions

Type	Name	Description
BIOLOGICAL	Dendritic Cell Vaccine	Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.
BIOLOGICAL	Tumor Lysate	Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
DRUG	Imiquimod	5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate
PROCEDURE	Leukapheresis	Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.

Timeline

• Start date: 2013-08-21
• Primary completion: 2018-11-07
• Completion: 2022-07-16
• First posted: 2013-03-11
• Last updated: 2022-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study