A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage
bevacizumab
+ magnetic resonance imaging
+ quality-of-life assessment
Squamous Cell Carcinoma of Head and Neck+38
+ Astrocytoma
+ Brain Diseases
Supportive Care Study
Summary
Study start date: June 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.11 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 * 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 cerebrovascular accident within the past 6 months * Myocardial infarction or unstable angina within the past 6 months * No clinically significant cardiovascular disease, including any of the following: * NYHA class II-IV congestive heart failure * Serious or inadequately controlled cardiac arrhythmia * Significant vascular disease (e.g., aortic aneurysm or history of aortic dissection) * Clinically significant peripheral vascular disease * At least 6 months since prior radiotherapy * Platelet count \> 75,000/mm\^3 * Granulocyte count \> 1,500/mm\^3 * Creatinine \< 1.0 times ULN * AST \< 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Prior chemotherapy for tumor allowed * Prior tyrosine kinase inhibitors of VEGF receptor (VEGFR) allowed * More than 28 days since prior and no concurrent major surgical procedure or open biopsy * Concurrent dexamethasone allowed provided patient is on a stable dose for \>= 1 week prior to study entry * Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided the following criteria are met: * In-range INR (usually between 2 and 3) and patient is on a stable dose of oral anticoagulant for 1 week or on a stable dose of low molecular weight heparin * No active bleeding or pathological condition that carries a high risk of bleeding * Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided the following criteria are met: No evidence of serious or nonhealing wound, ulcer, or bone fracture * No concurrent chemotherapy or tyrosine kinase inhibitors of VEGFR * No prior bevacizumab * More than 7 days since prior core biopsy * History of seizures allowed provided the patient is receiving anticonvulsant therapy * Hemoglobin \>= 9.0 g/dL * Bilirubin =\< 1.5 times upper limit of normal (ULN) * No other concurrent investigational agents
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location