NCT02669173

Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma

Targeting Myeloid Derived Suppressor Cells in Recurrent Glioblastoma: Phase 0/1 Trial of Low Dose Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Capecitabine	Drug given orally. Dose to be determined by phase 1 dose escalation, cycle length 28 days. Treatment until progression
DRUG	Bevacizumab	Drug given by IV, 10 mg/kg days 1, 15 every 28 days, until progression.

Timeline

• Start date: 2016-10-11
• Primary completion: 2025-01-07
• Completion: 2025-01-07
• First posted: 2016-02-01
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study