Study on Optune Electric Field Therapy and Bevacizumab for Treating Recurrent or Progressive Grade 2 or 3 Meningioma
Sponsor: Northwestern University
ClinicalTrials ID:NCT02847559
This clinical trial is testing a combination of a drug called bevacizumab and a device called Optune to see if they can help control the growth of meningiomas, a type of brain tumor. Both treatments are considered experimental for this condition.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using bevacizumab, a drug that blocks the growth of new blood vessels, together with Optune, a device that delivers electric fields to the brain, can help slow down or shrink meningiomas. Bevacizumab may stop tumors from growing by cutting off their blood supply, while Optune may slow tumor growth by interfering with cell division. Participants will use the Optune device for at least 18 hours a day and receive bevacizumab through an IV every two to three weeks. The study will monitor how well these treatments work together to control the tumor and improve patients' quality of life.
Description
The main goal of this study is to see if the combination of bevacizumab and Optune can keep the tumor from growing for at least six months in patients with recurrent or progressive meningioma. Researchers will also look at overall survival rates, how well the tumor responds to treatment, and the impact on patients' quality of life.
Participants will receive bevacizumab through an IV on specific days of each treatment cycle, which lasts 28 days. They will also use the Optune device daily for at least 18 hours. The treatment cycles will continue as long as the disease does not progress and side effects are manageable.
After finishing the study treatment, participants will have follow-up visits every three months for two years to monitor their health and any changes in the tumor.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of grade 2 or 3 meningioma.
- The tumor must be located in the supratentorial region of the brain.
- Must have evidence of tumor recurrence or progression, confirmed by MRI or CT scan.
- Must have received standard treatments, including surgery and radiation, if applicable.
- Must have a life expectancy of at least 12 weeks.
- Must have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
- Must have adequate bone marrow, kidney, and liver function based on specific blood test results.
- Women of childbearing potential and men with partners of childbearing potential must agree to use effective contraception during the study.
- Must be able to understand and sign a written informed consent form.
- Must be able to comply with all study requirements.
Exclusion Criteria
- Recent major surgery or significant injury within four weeks before starting the study.
- Recent minor surgery within seven days before starting the study.
- Tumors located in the infratentorial region or spine.
- Currently receiving other investigational drugs or anti-cancer therapies.
- Previous treatment with bevacizumab.
- Allergic reactions to similar drugs as bevacizumab.
- Active implanted medical devices or skull defects.
- Sensitivity to conductive gels used in medical devices.
- Significant protein in urine or serious non-healing wounds.
- History of significant bleeding or blood clotting disorders.
- Recent heart attack, stroke, or uncontrolled high blood pressure.
- History of severe allergic reactions to similar treatments.
- Pregnant or nursing women.
- Severe or uncontrolled medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| John Wayne Cancer Center at Providence St. John's Health Center | 90404 | Santa Monica | California |
| Miami Cancer Institute | 33176 | Miami | Florida |
| Piedmont Healthcare | 30309 | Atlanta | Georgia |
| Northwestern University | 60611 | Chicago | Illinois |
| Northwestern University- Lake Forest Hospital | 60045 | Lake Forest | Illinois |
| Northwestern Medicine/ Cadence Health - CDH | 60190 | Winfield | Illinois |
| Vidant Medical Center, East Caroling University | 27834 | Greenville | North Carolina |
| University of Pennsylvania | 19104 | Philadelphia | Pennsylvania |
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