A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab
- Conditions
- Adult Anaplastic Astrocytoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief 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.
Detailed Description
PRIMARY OBJECTIVE: I. Determine to what extent bevacizumab can reduce active radiation toxicity to the CNS in patients who have undergone cranial irradiation for primary brain neoplasm, meningioma, or head and neck cancer. SECONDARY OBJECTIVES: I. Determine to what extent this drug can reduce dexamethasone dependence in these patients. II. Determine to what extent this drug can improve neurologic function in these patients. III. Determine to what extent this drug can improve quality of life of these patients. OUTLINE: This is a randomized, placebo-controlled, crossover, double-blind study. Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients in arm II who have failed to respond to treatment at 6 or 12 weeks may cross over to arm I and receive 2 courses of bevacizumab as in arm I. Patients in arm I (including crossover patients) who have responded to treatment may receive 2 additional courses of bevacizumab. Patients undergo MRI after courses 2 and 4. Quality of life and neurologic function are assessed at baseline, periodically during study treatment, and at 12 and 24 weeks after completion of study treatment. After completion of study treatment, patients are followed at 12 and 24 weeks.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: bevacizumab
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: magnetic resonance imaging
Arm I
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: quality-of-life assessment
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: placebo
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: magnetic resonance imaging
Arm II
Patients receive placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Intervention: quality-of-life assessment
Outcomes
Primary Outcomes
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
Time Frame: Baseline to 12 weeks
Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.