Capecitabine + Bevacizumab for Glioblastoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment approach for individuals with recurrent glioblastoma, a type of brain tumor that has returned or continued growing despite previous treatments. The trial aims to determine if a combination of low-dose capecitabine (Xeloda) and bevacizumab (Avastin) can alter the tumor environment and reduce tumor size. Individuals with a confirmed diagnosis of grade 4 glioma who plan to have a tumor removed may be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment approach.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, there are specific intervals required from prior treatments, and certain medications like investigational agents and some HIV treatments are not allowed. It's best to discuss your current medications with the trial team to get a clear answer.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that the combination of capecitabine and bevacizumab is generally safe for patients with glioblastoma. In earlier studies, patients who took these drugs did not experience serious treatment-related side effects. Specifically, low doses of capecitabine with bevacizumab proved safe. This combination has been used in various cancer treatments without causing major side effects in these studies. Additionally, bevacizumab has been used for a long time in other types of solid tumors and has been well-tolerated over extended periods. These findings help reassure about the safety of these treatments in people.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about the combination of capecitabine and bevacizumab for glioblastoma because it introduces a new approach to tackling this aggressive brain cancer. Unlike the standard treatments that primarily focus on surgery, radiation, and chemotherapy such as temozolomide, this combo offers a unique mechanism by combining an oral chemotherapy agent, capecitabine, which disrupts cancer cell DNA, with bevacizumab, an IV-administered drug that inhibits blood vessel growth to the tumor. This dual-action strategy aims to not only directly attack cancer cells but also cut off their blood supply, potentially enhancing effectiveness and slowing tumor progression.
What evidence suggests that Capecitabine + Bevacizumab might be an effective treatment for glioblastoma?
Studies have shown that combining capecitabine and bevacizumab may help treat certain cancers. Specifically, research on patients with colorectal cancer found that this combination prevented cancer progression for an average of 10.3 months, with about 30% of patients experiencing tumor shrinkage. Although these results do not specifically apply to glioblastoma, they suggest that this drug combination might help control tumor growth in some cancers. In this trial, participants will receive capecitabine and bevacizumab to determine if these benefits extend to glioblastoma, focusing on immune cells that aid tumor survival.23678
Who Is on the Research Team?
David Peereboom, MD
Principal Investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low dose capecitabine and bevacizumab in 28-day cycles until progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Capecitabine
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Case Comprehensive Cancer Center
Lead Sponsor