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Bevacizumab With or Without Surgery for Adult Glioblastomas

Study Purpose

Background:

  • - Glioblastoma (GBM) is the most common malignant brain tumor in adults.
Patients with GBM are usually treated with surgery, radiation, and chemotherapy. Despite this treatment, most GBMs start growing again. Bevacizumab, a chemotherapy drug, has shown promise in slowing the growth of GBMs. More research is needed to find out whether having surgery before starting bevacizumab is more effective than bevacizumab alone. Objectives:
  • - To compare surgery plus bevacizumab to bevacizumab alone in adults with glioblastoma.
Eligibility:
  • - Individuals at least 18 years old whose glioblastoma has come back after treatment.
Design:
  • - All participants will be screened with a physical exam, medical history, blood tests, and imaging studies.
  • - Participants will be divided into two groups.
One group will have surgery followed by bevacizumab. The other group will have the drug without surgery.
  • - The first group will have surgery as soon as possible and will begin bevacizumab 4 weeks after surgery.
The second group will start the drug as soon as possible.
  • - Both groups will receive the drug as an infusion every 2 weeks.
They will be monitored with frequent blood tests and imaging studies. The infusions will continue for as long as the drug is effective at preventing tumor regrowth.
  • - Participants will be contacted every 4 weeks after they stop taking bevacizumab.
They will answer followup questions either in person or by telephone.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

  • -

    INCLUSION CRITERIA:

    Previous diagnosis of supratentorial GBM established by WHO histological criteria.
Age 18 or older.NRGS score of 0 to 2 established by the following criteria:
  • - KPS 80 or less (1 point) - Tumor volume 50 cc or greater (1 point) - Tumor involvement of at least 2 of the following brain areas (1 point): - Motor cortex.
  • - Language cortex.
  • - Areas directly adjacent to the proximal (M1 and/or M2) middle cerebral artery.
Received initial treatment for GBM with:
  • - External beam radiation therapy.
  • - Nitrosourea or temozolomide chemotherapy.
  • - Biopsy, subtotal or gross total resection.
Evidence of recurrence, defined as the appearance or enlargement since previous imaging of a contrast-enhancing mass on T1-weighted MRI.Have a non-deep (involving basal ganglia, thalamus, or periventricular region), non-diffuse recurrence judged to be resectable by a neurosurgeon.Able to provide informed consent.

EXCLUSION CRITERIA:

NRGS score of 3.Patients requiring biopsy only or other procedures where the goal is not tumor cytoreduction.Patients who require urgent or emergency surgery due to symptoms of raised intracranial pressure or herniation.Patients who have already received bevacizumab therapy.Contraindication to surgery as determined by a neurosurgeon, including bleeding diathesis, unacceptable pulmonary or cardiovascular risk, significant wound healing concerns, or tumor recurrence judged to be inoperable, inaccessible, or diffuse.Contraindication to bevacizumab as determined by a neuro-oncologist, including unacceptable end organ function, evidence of acute intracranial hemorrhage, or recent or active use of anticoagulants.Contraindication to MRI scanning as determined by a radiologist, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments.Pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01413438
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 John K Park, M.D.
Principal Investigator Affiliation National Institute of Neurological Disorders and Stroke (NINDS)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Withdrawn
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Brain Neoplasm
Additional Details

Objective.The objective of this prospective randomized controlled study is to determine the overall survival benefit of tumor resection in patients with recurrent glioblastoma multiforme (GBM). Study Population.This study will recruit 42 adults with a diagnosis of recurrent grade 4 astrocytoma into each of two arms, for a total of 84 patients. All participants will be good candidates for elective surgical resection of their tumors according to the previously established NIH Recurrent Glioma Scale (NRGS), which uses performance status, tumor volume, and tumor involvement of critical/eloquent brain areas as prognostic criteria. Patients who require biopsy only or have previously been treated with bevacizumab will be excluded. Design.Participants will be stratified by NRGS score (NRGS 0 or NRGS 1-2) and randomized to surgery followed by bevacizumab or to bevacizumab alone. Patients assigned to the surgical arm will undergo their procedure within 28 days of randomization. Treatment with bevacizumab at a dose of 10 mg/kg every 2 weeks will begin at least 28 days later to allow adequate craniotomy wound healing. Patients assigned to the non-surgical arm will start bevacizumab at a dose of 10 mg/kg every 2 weeks immediately. MRI evaluations will take place within 72 hours of surgery to assess extent of resection, 28 days postoperatively, 96 hours after starting bevacizumab, and then every 28 days until tumor progression is documented. Follow-up assessments will take place every 28 days while on bevacizumab until tumor progression. Once progression is established, patients will be free to pursue further surgical and/or medical salvage therapy as they wish. Patients will be followed until their time of death. Outcome Measures.The primary outcome measure is median overall survival from the date bevacizumab is started. Secondary outcome measures include the rate of progression-free survival 6 months after starting bevacizumab, median progression-free survival, overall survival rates at 6 and 12 months after starting bevacizumab, objective response rate, health-related quality of life, change in KPS of 20 points or more, time to need for additional tumor therapy, and use of corticosteroids.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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