Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2019-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Brain Cancer Neoplasm Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Personalized cellular vaccine

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

Group Type EXPERIMENTAL

Personalized cellular vaccine

Intervention Type 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

Interventions

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Personalized cellular vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No