Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the … (NCT00492089) | Clinical Trial Compass
CompletedPhase 2
Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer
United States11 participantsStarted 2007-06
Plain-language summary
Bevacizumab may reduce CNS side effects caused by radiation therapy. This randomized phase II trial is studying how well bevacizumab works in reducing CNS side effects in patients who have undergone radiation therapy to the brain for primary brain tumor, meningioma, or head and neck cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* No evidence of bleeding diathesis or coagulopathy
* Fertile patients must use effective contraception during and for \>= 2 months after completion of study therapy
* No diarrhea \>= grade 1
* Histologically confirmed primary brain neoplasm, meningioma, or head and neck cancer \[WHO grade 2 or 3 disease--no WHO grade 4 primary brain neoplasms (i.e., glioblastoma or gliosarcoma)\]
* Patients with head and neck cancer must not have any of the following:
* Evidence of metastatic disease
* Evidence of tumor invasion to major vessels (e.g., the carotid)
* History of bleeding related to tumor or radiotherapy during or after completion of radiotherapy
* Must have undergone cranial irradiation
* Must have radiographic evidence to support the diagnosis of radiation necrosis and/or surgical biopsy evidence of necrosis without tumor within the past 2 months
* Must have evidence of progressive neurologic signs or symptoms appropriate to the location of the radiation necrosis
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No significant traumatic injury within the past 28 days
* No evidence of active CNS hemorrhage
* Karnofsky performance status 60-100%
* No clinically significant cardiovascular disease, including any of the following:
* Inadequately controlled hypertension (i.e., systolic BP \> 140 mm Hg and/or diastolic BP \> 90 mm Hg despite antihypertensive medication)
* Large vessel cerebrov…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment