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Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3) (PerCellVac3)

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ClinicalTrials.gov Identifier: NCT02808416
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : June 21, 2016
Sponsor:
Collaborators:
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Jinan University Guangzhou
Information provided by (Responsible Party):
Jian Zhang, Guangdong 999 Brain Hospital

Brief Summary:
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 cellular vaccines. The patients will receive vaccines consisting of autologous tumor cells, tumor antigen pulsed DCs and peripheral blood mononuclear cells (PBMCs). Safety and efficacy will be observed in this study.

Condition or disease Intervention/treatment Phase
Brain Cancer Neoplasm Metastases Biological: Personalized cellular vaccine Phase 1 Phase 2

Detailed Description:
This is an open label, single-arm, single-institution, Phase I/II study designed to investigate the safety and efficacy of personalized cellular tumor vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. Tumor cells will be irradiated and used as vaccines. The patients will be immunized with DCs and PBMCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with a total of twelve tumor vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the efficacy of the vaccines using RANO-BM criteria, progression-free survival and overall survival. In addition, the antitumor specific T cell responses will be measured.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.

Other Names:

• Tumor antigen pulsed DC and PBMC, autologous tumor vaccine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 24 months since the beginning of the first vaccine ]
    Progression-free survival will be monitored for 2 year

  2. Overall survival [ Time Frame: 3 years since the beginning of the first vaccine ]
    Overall survival will be monitored for 3 years

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Ying Nie, M.D. 011 86 13609015565 drnieying@163.com
Contact: Qingting Wang, M.S. wangqianting999@163.com

Locations
China, Guangdong
Guangdong 999 Brain Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Ying Nie, M.D.    011 86 13609015565    drnieying@163.com   
Contact: Qianting Wang, M.S.       wangqianting999@163.com   
Principal Investigator: Jian Zhang, M.D.         
Principal Investigator: You-Wen He, M.D. Ph.D.         
Sponsors and Collaborators
Guangdong 999 Brain Hospital
Beijing Tricision Biotherapeutics Inc
Guangzhou Trinomab Biotech Co., Ltd.
Jinan University Guangzhou
Investigators
Principal Investigator: Jian Zhang, M.D. Guangdong 999 Brain Hospital

Responsible Party: Jian Zhang, Vice President of the hospital and Chief Physician, Guangdong 999 Brain Hospital
ClinicalTrials.gov Identifier: NCT02808416     History of Changes
Other Study ID Numbers: Ag-mRNA-Cell-BM-999Brain
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jian Zhang, Guangdong 999 Brain Hospital:
Solid tumors
Brain metastases
DC vaccine
Personalized vaccine
Tumor antigens
PBMCs

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs