← Back to Search

Monoclonal Antibodies

Capecitabine for Glioblastoma

Q: What are the odds of experiencing severe side effects from Capecitabine?

Given that this is a Phase 1 trial with limited data supporting both safety and efficacy, our team has scored capecitabine a 1.

Q: What are the most common ailments that capecitabine has been shown to improve?

While typically taken to treat <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a> that has become resistant to platinum-based drugs, capecitabine can also be used to fight malignant neoplasms, primary peritoneal cancer, and nonsquamous non-<a href="https://www.withpower.com/clinical-trials/small-cell-lung-cancer">small cell lung cancer</a>.

Q: Do we have any historical context for using Capecitabine?

There are 694 ongoing studies investigating capecitabine with 218 of them being in Phase 3. Additionally, there are many different trial locations for this medication with 30834 being registered globally.

Phase 1

Waitlist Available

Led By David Peereboom, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must not have received capecitabine or bevacizumab for this disease

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up nine months

Awards & highlights

Study Summary

This trial is testing a new way to treat brain tumors by targeting the cells that help the tumor grow.

Who is the study for?

This trial is for adults with recurrent glioblastoma who have not been treated with capecitabine or bevacizumab. They must have a stable physical condition, no major bleeding risks, controlled blood pressure, and the ability to swallow tablets. Pregnant women and those with certain infections or recent heart issues are excluded.Check my eligibility

What is being tested?

The study tests if low dose capecitabine can target MDSCs to potentially reverse immunosuppression in the brain tumor environment of GBM patients, combined with bevacizumab which may help reduce tumors by inhibiting blood vessel growth.See study design

What are the potential side effects?

Potential side effects include diarrhea, fatigue, risk of infection due to bone marrow suppression, high blood pressure from bevacizumab use; also possible allergic reactions to either drug's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have not been treated with capecitabine or bevacizumab for my condition.

Select...

My blood and organ tests meet the study's requirements.

Select...

I can care for myself but may need occasional help.

Select...

I am on full-dose anticoagulants and meet the specific criteria.

Select...

I can swallow whole tablets.

Select...

I have a grade 4 brain tumor and am scheduled for surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ eight months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~eight months

This trial's timeline: 3 weeks for screening, Varies for treatment, and eight months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

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

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

+1 more

Other outcome measures

To obtain a signal for efficacy as measured by progression-free survival rate at 6 months

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment: Capecitabine + BevacizumabExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capecitabine

2013

Completed Phase 3

~3420

Bevacizumab

2013

Completed Phase 4

~5280

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,898 Total Patients Enrolled

15 Trials studying Glioblastoma

434 Patients Enrolled for Glioblastoma

David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

9 Previous Clinical Trials

391 Total Patients Enrolled

9 Trials studying Glioblastoma

391 Patients Enrolled for Glioblastoma

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02669173 — Phase 1

Glioblastoma Research Study Groups: Treatment: Capecitabine + Bevacizumab

Glioblastoma Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT02669173 — Phase 1

Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02669173 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the odds of experiencing severe side effects from Capecitabine?

"Given that this is a Phase 1 trial with limited data supporting both safety and efficacy, our team has scored capecitabine a 1."

Answered by AI

What are the most common ailments that capecitabine has been shown to improve?

"While typically taken to treat ovarian cancer that has become resistant to platinum-based drugs, capecitabine can also be used to fight malignant neoplasms, primary peritoneal cancer, and nonsquamous non-small cell lung cancer."

Answered by AI

Do we have any historical context for using Capecitabine?

"There are 694 ongoing studies investigating capecitabine with 218 of them being in Phase 3. Additionally, there are many different trial locations for this medication with 30834 being registered globally."

Answered by AI

Recent research and studies

JCI InsightJournal

Metronomic Capecitabine as an Immune Modulator in Glioblastoma Patients Reduces Myeloid-derived Suppressor Cells

Peereboom, David M., Tyler J. Alban, Matthew M. Grabowski, Alvaro G. Alvarado, Balint Otvos, Defne Bayik, Gustavo Roversi, et al.. 2019. “Metronomic Capecitabine as an Immune Modulator in Glioblastoma Patients Reduces Myeloid-derived Suppressor Cells”. JCI Insight. American Society for Clinical Investigation. doi:10.1172/jci.insight.130748.

clinicaltrials.govStudy

Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma

2016. "Capecitabine + Bevacizumab in Patients With Recurrent Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02669173.

All > Recurrent Glioblastoma > Glioblastoma Multiforme