Clinical trial · Interventional
Study of DC Vaccination Against Glioblastoma
A Triple-blind Randomized Clinical Study of Vaccination With Dendritic Cells Loaded With Glioma Stem-like Cells Associated Antigens Against Brain Glioblastoma Multiform
NCT01567202CI-TRIAL-00047041unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II study in a single center to determine the efficacy of autologous dendritic cells (DCs) loaded with autogeneic glioma stem-like cells (A2B5+) administered as a vaccination in adults with glioblastoma multiforme (primary or secondary).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blank placebo | Drug | — | UNRESOLVED |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| DC vaccination | Biological | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm DC
- description
- In this arm, the patients will receive DC vaccination in addition to the standard therapy, including Surgery, Chemotherapy, and Radiotherapy.
- interventionNames
- Procedure: Surgery
- Drug: Chemotherapy
- Radiation: Radiotherapy
- Biological: DC vaccination
- type
- PLACEBO_COMPARATOR
- label
- Arm Placebo
- description
- In this arm, the patients will receive blank placebo instead of the DC vaccination in addition to the standard therapy.
- interventionNames
- Procedure: Surgery
- Drug: Chemotherapy
- Radiation: Radiotherapy
- Drug: blank placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed brain glioblastoma multiforme and molecular subgroups of IDH1 wildtype TERT mutation。 2. Patients with maximum safe resection of the tumor (≥95%) confirmed with contrast MR within 72 hours after surgery. 3. Age from 18 through 70 years. 4. Karnofsky performance score of ≥ 60%. 5. Adequate organ function within 14 days of study registration including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count, (ANC) ≥ 1.0×10\^9/L, platelets ≥100×10\^9/L; hemoglobin ≥ 9 g/dL. Hepatic: bilirubin ≤1.3 mg/dL or 0-22 mmol/L, aspartate transaminase (AST) and alanine transaminase (ALT) \< 3×upper limit of normal (ULN). Renal: Normal serum Creatinine for age (below) or creatinine clearance \>60 ml/min/1.73 m\^2. Electrocardiogram: normal. 6. Written informed consent must be obtained from all patients, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: 1. Pregnant or breast-feeding patients. Pregnancy testing will be performed on all menstruating females within 14 days of study enrollment. 2. Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Patients with history of immune system abnormalities such as hyperimmunity (e.g., autoimmune diseases) and hypoimmunity (e.g., myelodysplastic disorders, marrow failures, AIDS, ongoing pregnancy, transplant immuno-suppression), or medication of cortisol. 4. Patients with any conditions that could potentially alter immune function (e.g., AIDS, multiple sclerosis, diabetes, renal failure). 5. Patients currently received any other investigational agents.
References
Publications (4)
- BACKGROUNDHua W, Yao Y, Chu Y, Zhong P, Sheng X, Xiao B, Wu J, Yang B, Mao Y, Zhou L. The CD133+ tumor stem-like cell-associated antigen may elicit highly intense immune responses against human malignant glioma. J Neurooncol. 2011 Nov;105(2):149-57. doi: 10.1007/s11060-011-0572-y. Epub 2011 Apr 11. PMID 21479962
- BACKGROUNDHua Wei, Yao Yu, Chu Yiwei, Zhong Ping, Zhang Rong, Zhu Wei, Wu Jingsong, Ma Dexuan, Xu Ming, Mao Ying, Zhou Liangfu. Phase I study of dendritic cells pulsed with tumor stem-like cells associated antigens against malignant glioma in recurrent patients. Chinese Journal of Neurosurgery (Chinese). 2011, 27(1): 90-94.
- BACKGROUNDXu M, Yao Y, Hua W, Wu Z, Zhong P, Mao Y, Zhou L, Luo F, Chu Y. Mouse glioma immunotherapy mediated by A2B5+ GL261 cell lysate-pulsed dendritic cells. J Neurooncol. 2014 Feb;116(3):497-504. doi: 10.1007/s11060-013-1334-9. Epub 2014 Jan 8. PMID 24398615
- BACKGROUNDYao Y, Luo F, Tang C, Chen D, Qin Z, Hua W, Xu M, Zhong P, Yu S, Chen D, Ding X, Zhang Y, Zheng X, Yang J, Qian J, Deng Y, Hoon DSB, Hu J, Chu Y, Zhou L. Molecular subgroups and B7-H4 expression levels predict responses to dendritic cell vaccines in glioblastoma: an exploratory randomized phase II clinical trial. Cancer Immunol Immunother. 2018 Nov;67(11):1777-1788. doi: 10.1007/s00262-018-2232-y. Epub 2018 Aug 22. PMID 30159779