Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma

Status Active, not recruiting

Clinical Trial Summary

This study involves participants with recurrent glioblastoma brain tumors (GBM). This means that a participant's brain tumor has either returned after being treated by a previous therapy, or has continued to progress despite being treated. The purpose of this study is to provide proof of concept that suppression of MDSCs (myeloid-derived suppressor cells) is feasible in patients with GBM. Rather than targeting tumor cells or immune checkpoints, which has been the focus of recent therapeutic efforts, direct targeting of MDSCs with low dose capecitabine has the potential to reverse the immunosuppressed microenvironment of GBM and thereby reduce tumors

Clinical Trial Description

Primary Objective: To achieve a 20-fold MDSC reduction in the concentration of circulating MDSCs after treatment with low dose capecitabine. Secondary Objectives: 1. To determine the concentration of circulating MDSCs in patients with recurrent glioblastoma after treatment with low dose capecitabine 2. To determine the concentration of tissue MDSCs and T-regulatory cells in resected glioblastoma after treatment with low dose capecitabine 3. To determine the safety and toxicity of continuous low dose capecitabine with and without standard dose bevacizumab. Exploratory Objective: To obtain a signal for efficacy as measured by progression-free survival rate at 6 months ;

Study Design

Related Conditions & MeSH terms

Glioblastoma

Clinical Trial Details

NCT number	NCT02669173
Study type	Interventional
Source	Case Comprehensive Cancer Center
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	October 11, 2016
Completion date	November 1, 2024

View Details

See also
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