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Brain CancerPhase 1PerCellVac3NCT02808416

Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

A Phase 1 study testing Personalized cellular vaccine in people with Brain Cancer and Neoplasm Metastases, run by Guangdong 999 Brain Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Brain Cancer, Neoplasm Metastases
What is being tested?
Personalized cellular vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Mar 2016to 30 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong 999 Brain Hospital

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Read the detailed description

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.

Being tested
Personalized cellular vaccine
Keywords
Solid tumors, Brain metastases, DC vaccine, Personalized vaccine, Tumor antigens
Medical subject headings
Brain Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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
Study groups in NCT02808416
Study groupRoleWhat they receive
Personalized cellular vaccineExperimentalPatients will undergo tumor resection or biopsy, and receive biweekly cellular vaccines consisting of mRNA-pulsed autologous DCs.
Receives: Biological: Personalized cellular vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years since the beginning of the first vaccine

Secondary outcomes (3)

  1. Antitumor specific T cell response

    The frequency of the peripheral CD8+ and CD4+ T cell response to the vaccine will be measured.

    Measured: 4 weeks after the last vaccine

  2. Progression-free survival

    Progression-free survival will be monitored for 2 year

    Measured: 24 months since the beginning of the first vaccine

  3. Overall survival

    Overall survival will be monitored for 3 years

    Measured: 3 years since the beginning of the first vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2016 (estimated)
  2. Study start1 Mar 2016
  3. Primary completion31 Oct 2017
  4. Study completion30 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02808416
Sponsor's protocol ID
Ag-mRNA-Cell-BM-999Brain
Acronym
PerCellVac3
Status last verified
May 2022
First submitted
17 Jun 2016
Last updated
27 May 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 32078016

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Personalized cellular vaccine in people with Brain Cancer and Neoplasm Metastases, run by Guangdong 999 Brain Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events and severe adverse events (safety and tolerability) (time frame: 3 years since the beginning of the first vaccine). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.

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