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 range18 Years
SexALL
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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…
What they're measuring
1
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment