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
A Randomized Phase II Trial of Bevacizumab to Control Brain Radiation Damage
6 other identifiers
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2007
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 25, 2007
CompletedFirst Posted
Study publicly available on registry
June 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedResults Posted
Study results publicly available
June 14, 2013
CompletedMay 9, 2014
April 1, 2013
3.2 years
June 25, 2007
June 15, 2012
April 21, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment
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.
Baseline to 12 weeks
Study Arms (2)
Arm I
EXPERIMENTALPatients 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
PLACEBO COMPARATORPatients 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.
Interventions
Given IV
Eligibility Criteria
You may qualify if:
- 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%
- +31 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Monica Loghin, MD / Assistant Professor
- Organization
- The University of Texas MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Loghin
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2007
First Posted
June 27, 2007
Study Start
June 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
May 9, 2014
Results First Posted
June 14, 2013
Record last verified: 2013-04