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About
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
Full description
Primary Objective: To achieve a 20-fold MDSC reduction in the concentration of circulating MDSCs after treatment with low dose capecitabine.
Secondary Objectives:
Exploratory Objective:
To obtain a signal for efficacy as measured by progression-free survival rate at 6 months
Enrollment
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Inclusion criteria
Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which a clinically indicated tumor resection is planned.
Subjects must not have received capecitabine or bevacizumab for this disease.
Performance status: Karnofsky Performance status ≥ 60%
Subjects must have adequate organ function and laboratory parameters within 21 days of study entry as defined below:
Hemoglobin ≥ 8 g/dl
Absolute neutrophil count ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
AST (SGOT) ≤ 3 X institutional ULN
ALT (SGPT) ≤ 3 X institutional ULN
Calculated creatinine clearance ≥ 50 mL/min
Urine protein screened by urine analysis for urine protein creatinine (UPC) ratio. For UPC ratio > 0.5, 24-hour urine protein must be obtained and must be < 1000 mg.
Prothrombin time/international normalized ratio (PT/INR) < 1.4 for patients not on warfarin
Patients on full-dose anticoagulants (e.g., warfarin or LMW heparin) must meet both of the following criteria:
Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential must have a negative pregnancy test within 21 days of study entry. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and through 30 days after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and through 30 days after the last dose of study drug.
Patients must be able to swallow whole tablets.
Systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90 mg Hg within 14 days prior to study registration
Electrocardiogram without evidence of acute cardiac ischemia within 14 days prior study registration
Patients must have the following minimum intervals from prior treatments:
Exclusion criteria
Primary purpose
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12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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