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Personalized Cellular Vaccine for Glioblastoma (PERCELLVAC)

2016-03-18 04:48:39 | BioPortfolio

Summary

Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. In addition, allogeneic peripheral blood mononuclear cells (PBMCs) will be used as cellular vehicle for immunization. Safety and efficacy will be observed in the study.

Description

This is a single-institution, open label, single-arm, Phase I/II study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be pre-conditioned for DC vaccination with either tetanus toxoid vaccine or imiquimod cream. Allogeneic PBMCs will be pulsed with tumor antigen mRNA. The patients will be immunized intradermally for a total of twelve times with DC or PMBC cellular 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 specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured by radiological response (MRI), iRANO, progression-free survival and overall survival.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma

Intervention

Personalized cellular vaccine

Location

Guangdong 999 Brain Hospital
Guangzhou
Guangdong
China

Status

Recruiting

Source

Guangdong 999 Brain Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-18T04:48:39-0400

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