About this trial
This study is designed with open-label and randomized parallel group to evaluate the efficacy and safety of autologous dendritic cell vaccination (ADCV01) as an add-on treatment for primary glioblastoma multiforme
Eligibility criteria
Qualifiers
Patients are ≥ 20 and ≤ 75 years of age at brain tumor resection surgery.
Patients with newly diagnosed single, primary, WHO grade IV, glioblastoma (except for locating on brainstem or cerebellum) scheduled to undergo craniotomy tumor excision, and are willing to preserve the resected tumor cells enabling the production of ADCV01.
Patients undergo tumor resection by aid of neuro-navigation without receiving any intracranial implantation therapies (e.g., BCNU wafer).
Only one GBM tumor number.
Disqualifiers
Number of GBM is more than one
Patient who has participated in other investigational studies within 4 weeks prior to pre-screening
Patient with known or suspected hypersensitivity to ADCV01 or its excipients
Patient who has a history of hypersensitivity reaction (e.g., urticarial, allergic reaction including anaphylaxis, toxic epidermal necrosis, and Stevens-Johnson syndrome) to dacarbazine (DTIC) or any components of medications of temozolomide and bevacizumab
Trial design
Treatments tested in this trial
- autologous dendritic cells