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Monoclonal Antibodies

Capecitabine + Bevacizumab for Glioblastoma

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

Must not have

History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine or bevacizumab

Significant chronic gastrointestinal disorder with diarrhea as a major symptom

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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

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

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I can care for myself but may need occasional help.

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

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I can swallow whole tablets.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to medications similar to capecitabine or bevacizumab.

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I have a long-term stomach problem that causes severe diarrhea.

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I have not had a stroke or heart attack in the last 6 months.

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I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.

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I am HIV-positive and on combination antiretroviral therapy.

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My side effects from previous treatments are mild, except for hair loss or nerve issues.

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I cannot or do not want to swallow pills.

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I have an active hepatitis B or C infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4280

Bevacizumab

2013

Completed Phase 4

~5540