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
Status	Clinical Trial	Phase
Recruiting	`NCT05664243` - A Phase 1b / 2 Drug Resistant Immunotherapy With Activated, Gene Modified Allogeneic or Autologous γδ T Cells (DeltEx) in Combination With Maintenance Temozolomide in Subjects With Recurrent or Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT02768389` - Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma	Early Phase 1
Recruiting	`NCT05635734` - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma	Phase 1/Phase 2
Completed	`NCT03679754` - Evaluation of Ad-RTS-hIL-12 + Veledimex in Subjects With Recurrent or Progressive Glioblastoma, a Substudy to ATI001-102	Phase 1
Completed	`NCT01250470` - Vaccine Therapy and Sargramostim in Treating Patients With Malignant Glioma	Phase 1
Terminated	`NCT03927222` - Immunotherapy Targeted Against Cytomegalovirus in Patients With Newly-Diagnosed WHO Grade IV Unmethylated Glioma	Phase 2
Recruiting	`NCT03897491` - PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma	Phase 2
Active, not recruiting	`NCT03587038` - OKN-007 in Combination With Adjuvant Temozolomide Chemoradiotherapy for Newly Diagnosed Glioblastoma	Phase 1
Completed	`NCT01922076` - Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas	Phase 1
Recruiting	`NCT04391062` - Dose Finding for Intraoperative Photodynamic Therapy of Glioblastoma	Phase 2
Active, not recruiting	`NCT03661723` - Pembrolizumab and Reirradiation in Bevacizumab Naïve and Bevacizumab Resistant Recurrent Glioblastoma	Phase 2
Active, not recruiting	`NCT02655601` - Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001	Phase 2
Completed	`NCT02206230` - Trial of Hypofractionated Radiation Therapy for Glioblastoma	Phase 2
Completed	`NCT03493932` - Cytokine Microdialysis for Real-Time Immune Monitoring in Glioblastoma Patients Undergoing Checkpoint Blockade	Phase 1
Terminated	`NCT02709889` - Rovalpituzumab Tesirine in Delta-Like Protein 3-Expressing Advanced Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT06058988` - Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer	Phase 2
Completed	`NCT03018288` - Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM)	Phase 2
Not yet recruiting	`NCT04552977` - A Trail of Fluzoparil in Combination With Temozolomide in Patients With Recurrent Glioblastoma	Phase 2
Withdrawn	`NCT03980249` - Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells	Early Phase 1
Withdrawn	`NCT02876003` - Efficacy and Safety of G-202 in PSMA-Positive Glioblastoma	Phase 2