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GlioblastomaPhase 1NCT02669173

Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma

A Phase 1 study testing Capecitabine and Bevacizumab in people with Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Capecitabine and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
11 Oct 2016to 7 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

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

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

Read the 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
Keywords
Myeloid derived suppressor cells, brain tumor, MDSC, GBM, recurrent
Medical subject headings
Glioblastoma, Brain Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Drug given orally. Dose to be determined by phase 1 dose escalation, cycle length 28 days. Treatment until progression

  • BevacizumabDrug

    Drug given by IV, 10 mg/kg days 1, 15 every 28 days, until progression.

Study groups in NCT02669173
Study groupRoleWhat they receive
Treatment: Capecitabine + BevacizumabExperimentalCapecitabine, 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.
Receives: Drug: Capecitabine; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of concentration in circulating MDSCs after treatment with low dose capecitabine

    Measured: baseline to eight months after

Secondary outcomes (4)

  1. Concentration of MDSCs in resected glioblastoma after treatment with low dose capecitabine

    Measured: Eight months

  2. Concentration of T-regulatory cells after treatment with low dose capecitabine

    Measured: Eight months

  3. Number of participants with adverse events relating to treatment with low-dose capecitabine alone as assessed by CTCAE v4.0

    Measured: Nine months

  4. Number of participants with adverse events relating to treatment with low-dose capecitabine combined with bevacizumab as assessed by CTCAE v4.0

    Measured: Nine months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study start11 Oct 2016
  3. Primary completion7 Jan 2025
  4. Study completion7 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669173
Sponsor's protocol ID
CASE7315
Status last verified
Feb 2026
First submitted
21 Jan 2016
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Peereboom DM, Alban TJ, Grabowski MM, Alvarado AG, Otvos B, Bayik D, Roversi G, McGraw M, Huang P, Mohammadi AM, Kornblum HI, Radivoyevitch T, Ahluwalia MS, Vogelbaum MA, Lathia JD. Metronomic capecitabine as an immune modulator in glioblastoma patients reduces myeloid-derived suppressor cells. JCI Insight. 2019 Nov 14;4(22):e130748. doi: 10.1172/jci.insight.130748.

    PubMed 31600167

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Capecitabine and Bevacizumab in people with Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of concentration in circulating MDSCs after treatment with low dose capecitabine (time frame: baseline to eight months after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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