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NCT Number: NCT02808416

Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

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.

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Key information

Conditions

Brain Cancer Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong 999 Brain Hospital

Guangzhou, Guangdong, China

About this study

This is an open label, single-arm, single-institution, Phase I 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. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM criteria, progression-free survival and overall survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Personalized cellular vaccine

Biological

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

Primary outcomes

  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 vaccines.

Secondary outcomes

  1. 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.

  2. Progression-free survival

    Time frame: 24 months since the beginning of the first vaccine

    Progression-free survival will be monitored for 2 year

  3. Overall survival

    Time frame: 3 years since the beginning of the first vaccine

    Overall survival will be monitored for 3 years

Sponsors and collaborators

Lead sponsor

Guangdong 999 Brain Hospital

Other

Collaborators

  • Beijing Tricision Biotherapeutics Inc
  • Jinan University Guangzhou
  • Zhuhai Trinomab Pharmaceutical Co., Ltd.

Registry information

Official study title

Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors

Acronym: PerCellVac3

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jun 21, 2016
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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