NCT02808416

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

1.7 years

First QC Date

June 17, 2016

Last Update Submit

May 23, 2022

Conditions

Brain CancerNeoplasm Metastases

Keywords

Solid tumorsBrain metastasesDC vaccinePersonalized vaccineTumor antigens

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Antitumor specific T cell response

    4 weeks after the last vaccine

  • Progression-free survival

    24 months since the beginning of the first vaccine

  • Overall survival

    3 years since the beginning of the first vaccine

Study Arms (1)

Personalized cellular vaccine

EXPERIMENTAL

Patients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.

Biological: Personalized cellular vaccine

Interventions

Personalized cellular vaccineBIOLOGICAL

Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen mRNA pulsed cellular vaccines. Other Names: • Tumor antigen pulsed DC and PBMC, autologous tumor vaccine

Personalized cellular vaccine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, China

Location

Related Publications (1)

  • 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 Immunother. 2020 Jul;69(7):1375-1387. doi: 10.1007/s00262-020-02496-w. Epub 2020 Feb 20.

    PMID: 32078016RESULT

Related Links

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jian Zhang, M.D.

    Guangdong 999 Brain Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of the hospital and Chief Physician

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 21, 2016

Study Start

March 1, 2016

Primary Completion

October 31, 2017

Study Completion

June 30, 2019

Last Updated

May 27, 2022

Record last verified: 2022-05

Locations

CN(1)