Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02669173|
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : January 28, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma||Drug: Capecitabine Drug: Bevacizumab||Phase 1|
Primary Objective: To achieve a 20-fold MDSC reduction in the concentration of circulating MDSCs after treatment with low dose capecitabine.
- To determine the concentration of circulating MDSCs in patients with recurrent glioblastoma after treatment with low dose capecitabine
- To determine the concentration of tissue MDSCs and T-regulatory cells in resected glioblastoma after treatment with low dose capecitabine
- To determine the safety and toxicity of continuous low dose capecitabine with and without standard dose bevacizumab.
To obtain a signal for efficacy as measured by progression-free survival rate at 6 months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting Myeloid Derived Suppressor Cells in Recurrent Glioblastoma: Phase 0/1 Trial of Low Dose Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma|
|Actual Study Start Date :||April 20, 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Treatment: Capecitabine + Bevacizumab
Capecitabine, PO dose to be determined by phase 1 dose escalation, cycle length 28 days. Treated with Bevacizumab, IV, 10 mg/kg days 1, 15 every 28 days, until progression.
Drug given orally. Dose to be determined by phase 1 dose escalation, cycle length 28 days. Treatment until progression
Drug given by IV, 10 mg/kg days 1, 15 every 28 days, until progression.
- Change of concentration in circulating MDSCs after treatment with low dose capecitabine [ Time Frame: baseline to eight months after ]
- Concentration of MDSCs in resected glioblastoma after treatment with low dose capecitabine [ Time Frame: Eight months ]
- Concentration of T-regulatory cells after treatment with low dose capecitabine [ Time Frame: Eight months ]
- Number of participants with adverse events relating to treatment with low-dose capecitabine alone as assessed by CTCAE v4.0 [ Time Frame: Nine months ]
- Number of participants with adverse events relating to treatment with low-dose capecitabine combined with bevacizumab as assessed by CTCAE v4.0 [ Time Frame: Nine months ]
- To obtain a signal for efficacy as measured by progression-free survival rate at 6 months [ Time Frame: Six months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669173
|Contact: David Peereboom, MDemail@example.com|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: David Peereboom, MD 216-445-6068 firstname.lastname@example.org|
|Principal Investigator: David Peereboom, MD|
|Principal Investigator:||David Peereboom, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|