Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3) (PerCellVac3)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02808416|
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Brain Cancer Neoplasm Metastases||Biological: Personalized cellular vaccine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2019|
Experimental: Personalized cellular vaccine
Patients will undergo tumor resection or biopsy, and receive a total of 12 cellular vaccines consisting of autologous tumor cells, autologous DCs or allogeneic PBMCs.
Biological: Personalized cellular vaccine
Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen pulsed cellular vaccines.
• Tumor antigen pulsed DC and PBMC, autologous tumor vaccine
- Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) [ Time Frame: 3 years since the beginning of the first vaccine ]Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC, allogeneic PBMCs and autologous tumor cellular vaccines.
- Progression-free survival [ Time Frame: 24 months since the beginning of the first vaccine ]Progression-free survival will be monitored for 2 year
- Overall survival [ Time Frame: 3 years since the beginning of the first vaccine ]Overall survival will be monitored for 3 years
- Antitumor specific T cell response [ Time Frame: 4 weeks after the last vaccine ]The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808416
|Contact: Ying Nie, M.D.||011 86 firstname.lastname@example.org|
|Contact: Qingting Wang, M.S.||email@example.com|
|Guangdong 999 Brain Hospital||Recruiting|
|Guangzhou, Guangdong, China|
|Contact: Ying Nie, M.D. 011 86 13609015565 firstname.lastname@example.org|
|Contact: Qianting Wang, M.S. email@example.com|
|Principal Investigator: Jian Zhang, M.D.|
|Principal Investigator: You-Wen He, M.D. Ph.D.|
|Principal Investigator:||Jian Zhang, M.D.||Guangdong 999 Brain Hospital|