Brain Cancer Clinical Trial
— PerCellVac3Official title:
Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors
Verified date | May 2022 |
Source | Guangdong 999 Brain Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy will be observed in this study.
Status | Completed |
Enrollment | 10 |
Est. completion date | June 30, 2019 |
Est. primary completion date | October 31, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Solid tumor with brain metastases. - Patients at the age of 18-65. - Patients undergo tumor resection or biopsy. - Patients with Karnofsky scores > or =70 - Patients with normal range of hematologic and metabolic test results. - Patients must have no corticosteroids treatment at least one week before vaccination. - Patients capable of understanding the study and signed informed consent. Exclusion Criteria: - Infectious diseases HIV, HBV, HCV. - Documented immunodeficiency. - Documented autoimmune disease. - Breast feeding females. - Pregnant women. - Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease. - Patient inability to participate as determined by PI discretion. |
Country | Name | City | State |
---|---|---|---|
China | Guangdong 999 Brain Hospital | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong 999 Brain Hospital | Beijing Tricision Biotherapeutics Inc, Jinan University Guangzhou, Trinomab Biotech Co., Ltd. |
China,
Wang QT, Nie Y, Sun SN, Lin T, Han RJ, Jiang J, Li Z, Li JQ, Xiao YP, Fan YY, Yuan XH, Zhang H, Zhao BB, Zeng M, Li SY, Liao HX, Zhang J, He YW. Tumor-associated antigen-based personalized dendritic cell vaccine in solid tumor patients. Cancer Immunol Imm — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) | Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC vaccines. | 3 years since the beginning of the first vaccine | |
Secondary | Antitumor specific T cell response | The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured. | 4 weeks after the last vaccine | |
Secondary | Progression-free survival | Progression-free survival will be monitored for 2 year | 24 months since the beginning of the first vaccine | |
Secondary | Overall survival | Overall survival will be monitored for 3 years | 3 years since the beginning of the first vaccine |
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