Capecitabine + Bevacizumab for Glioblastoma

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Case Comprehensive Cancer Center

Must not be taking: Antiretrovirals

Disqualifiers: Uncontrolled illness, HIV, other malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: Variable (until progression)

12 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

David Peereboom, MD

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patients must have specific minimum intervals from prior treatments

Women of childbearing potential must have a negative pregnancy test within 21 days of study entry and agree to use adequate contraception

Systolic blood pressure ≤ 160 mg Hg or diastolic pressure ≤ 90 mg Hg within 14 days prior to study registration

Exclusion Criteria

I am allergic to medications similar to capecitabine or bevacizumab.

Subjects with uncontrolled intercurrent illness

I haven't had any other cancer besides this one in the last 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low dose capecitabine and bevacizumab in 28-day cycles until progression

Variable (until progression)

Visits on days 1 and 15 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Bevacizumab
• Capecitabine

Trial Overview 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.

Participant Groups

Group I: Treatment: Capecitabine + Bevacizumab Experimental Treatment 2 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.

Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Avastin for:

• Colorectal cancer
• Breast cancer
• Non-small cell lung cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in United States as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Glioblastoma
• Renal cell carcinoma
• Cervical cancer
• Ovarian cancer

Approved in Japan as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Approved in Canada as Avastin for:

• Colorectal cancer
• Non-small cell lung cancer
• Breast cancer
• Renal cell carcinoma
• Ovarian cancer

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+