NCT04552886

Dendritic Cell Vaccination With Standard Postoperative Chemoradiation for the Treatment of Adult Glioblastoma

A Phase I Study of Th-1 Dendritic Cell Immunotherapy in Combination With Standard Chemoradiation for the Adjuvant Treatment of Adult Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Effective treatments are desperately needed for glioblastoma (GBM) patients. This phase I clinical trial assesses the safety of a novel personalized dendritic-cell vaccine administered to GBM patients shortly after completing standard-of-care treatments. Secondary outcomes will evaluate patient progression-free survival and overall survival.

Detailed description

This is a single arm (non-randomized) first-in-man pilot study to evaluate the safety and feasibility of delivering a dendritic cell vaccine in nine to twenty-four (n=9-24) adult patients diagnosed with glioblastoma (GBM) after undergoing neurosurgical tumor resection, and in whom a neuropathological diagnosis has been established. Standard of care chemotherapy and radiation therapy shall be followed as per routine neuro-oncologic paradigms after which patients enrolled into this study will receive a personalized vaccine beyond standard of care. Effective adjuvant therapies are urgently needed for these patients given that standard of care is rarely successful in preventing recurrence among GBM patients, nor death among relapsed patients with this very poor-prognosis tumor type. The study is constructed in a 3+3 algorithm for three steps of dose escalation with rigorous and mandatory safety monitoring.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
BIOLOGICAL	TH-1 Dendritic Cell Immunotherapy	Adult patients with histopathologically diagnosed glioblastoma will be eligible for this novel, personalized dendritic cell vaccine after completing standard of care chemoradiation.

Timeline

• Start date: 2021-10-11
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2020-09-17
• Last updated: 2024-01-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study