New hope for recurrent brain cancer? early trial targets immune suppression
NCT ID NCT02669173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tested a combination of two drugs (low-dose capecitabine and bevacizumab) in 12 people whose glioblastoma brain tumor had come back or continued growing despite prior treatment. The goal was to see if the drugs could reduce certain immune cells (MDSCs) that help the tumor hide from the body's defenses. The study focused on safety and biological effects, not on curing the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
12 people
The number who actually took part.
- Started
-
Oct 2016
- Finished
-
Jan 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices) * In-range international normalized ratio (between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin * 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: * surgery - 4 weeks * nitrosoureas - 6 weeks * cytotoxic chemotherapy - standard intervals depending on the most recent regimen. i.e., for temozolomide 5 of 28, 23 days after most recent temozolomide; for temozolomide 21 of 28 days, 7 days after most recent dose; etoposide 14 of 21 days, 7 days after last dose. For drugs not listed, the research nurse, treating investigator, and principal investigator will determine the appropriate interval. * Investigational therapy or non cytotoxic therapy - 2 weeks Exclusion Criteria: * Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 4.0 except alopecia and neuropathy. * Subjects receiving any other investigational agents. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or bevacizumab. * Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with capecitabine and/or bevacizumab. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. * Other malignancy within the past 2 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the cervix or vulva; c) prostate cancer of Gleason Score 6 or less with stable prostate-specific antigen levels; or d) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas. * Significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events Version 4.0 \[CTCAE v.4.0\] diarrhea of any etiology at screening). * Active infection with hepatitis B or hepatitis C virus. * Pregnant or breastfeeding. * Known dihydropyrimidine dehydrogenase deficiency. * Known hypersensitivity to 5-fluorouracil, capecitabine, bevacizumab or to any component of the investigational products or compounds of similar chemical composition. * Unable or unwilling to swallow tablets. * Evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator's judgment, make the patient inappropriate for this study. * Arterial ischemic event (e.g., unstable angina, myocardial infarction, stroke) within 6 months of study entry
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Glioblastoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a trio of repurposed drugs shrink recurrent brain tumors?
- Can an existing drug boost bevacizumab against recurrent brain cancer?
- One extra radiation dose after standard brain cancer therapy: can it boost the immune system?
- Radioactive tracer lights up Oxygen-Starved brain tumors
- Can a common virus vaccine help fight brain cancer?
- Radioactive tiles target brain tumors in frail patients