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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Adult patients with histopathologically diagnosed glioblastoma will be eligible for this novel, personalized dendritic cell vaccine after completing standard of care chemoradiation.
Cooper University Hospital
Camden, New Jersey, United States
Memorial Hermann- Texas Medical Center
Houston, Texas, United States
Safety and potential toxicity of Th-1 dendritic cell immunotherapy
Patients will be monitored for adverse events as dictated by CTCAE version 5.
Time frame: Two years
Overall survival of patients receiving Th-1 dendritic cell immunotherapy
Length of survival for patients who receive this vaccine will be tabulated.
Time frame: Minimum 2 years from time of diagnosis
Progression-free survival of patients receiving Th-1 dendritic cell immunotherapy
If there is tumor recurrence, the time from diagnosis until recurrence will be collected
Time frame: Minimum 2 years from time of diagnosis
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