NCT00492089 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-05-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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 * 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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 Names
Drug: bevacizumab
Procedure: magnetic resonance imaging
Procedure: quality-of-life assessment
label
Arm I
type
EXPERIMENTAL
description
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 Names
Drug: placebo
Procedure: magnetic resonance imaging
Procedure: quality-of-life assessment
label
Arm II
type
PLACEBO_COMPARATOR

interventions

arm Group Labels
Arm I
description
Given IV
name
bevacizumab
other Names
anti-VEGF humanized monoclonal antibody
anti-VEGF monoclonal antibody
Avastin
rhuMAb VEGF
type
DRUG
arm Group Labels
Arm II
description
Given IV
name
placebo
other Names
PLCB
type
DRUG
arm Group Labels
Arm I
Arm II
name
magnetic resonance imaging
other Names
MRI
NMR imaging
NMRI
nuclear magnetic resonance imaging
type
PROCEDURE
arm Group Labels
Arm I
Arm II
name
quality-of-life assessment
other Names
quality of life assessment
type
PROCEDURE

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: PARTICIPANT
CARE_PROVIDER

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 11
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
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

Full study description

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.

Source references

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice