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GlioblastomaPhase 2NCT01413438

Bevacizumab With or Without Surgery for Adult Glioblastomas

A Phase 2 study testing Craniotomy in people with Glioblastoma and Brain Neoplasm, run by National Institute of Neurological Disorders and Stroke (NINDS).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma, Brain Neoplasm
What is being tested?
Craniotomy
Type of treatment
Surgery or procedure
How many people
0 participants
Where
No sites listed yet
Study dates
15 Jul 2011to 26 Sep 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 16Show fewer
  • 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

Who cannot join

  • 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

About this study

Official title: Prospective, Randomized Controlled Trial of Surgical Resection Prior to Bevacizumab Therapy for Recurrent Glioblastoma Multiforme

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.
Read more

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.
Read the detailed description

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.

Being tested
Craniotomy
Keywords
Bevacizumab, Quality of Life, Glioblastoma Multiforme, Neurosurgery, Glioblastoma, GBM, Brain Tumor
Medical subject headings
Glioblastoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CraniotomyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Overall Survival

    Measured: 2 years

Secondary outcomes (1)

  1. Progression-free survival (PFS) at 6 months & median PFS in each arm, objective response rate by the RANO criteria (OR), and overall survival rate at 6 and 12 months in each arm, compare rate of change in health-related quality of life.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2011 (estimated)
  2. Study start15 Jul 2011
  3. Primary completion26 Sep 2013
  4. Study completion26 Sep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01413438
Sponsor's protocol ID
110204
Other IDs
11-N-0204
Status last verified
26 Sep 2013
First submitted
9 Aug 2011
Last updated
2 Jul 2017
Results posted
No

Publications

  • Arko L, Katsyv I, Park GE, Luan WP, Park JK. Experimental approaches for the treatment of malignant gliomas. Pharmacol Ther. 2010 Oct;128(1):1-36. doi: 10.1016/j.pharmthera.2010.04.015. Epub 2010 Jun 8.

    PubMed 20546782

  • Clarke J, Butowski N, Chang S. Recent advances in therapy for glioblastoma. Arch Neurol. 2010 Mar;67(3):279-83. doi: 10.1001/archneurol.2010.5.

    PubMed 20212224

  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330.

    PubMed 15758009

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Craniotomy in people with Glioblastoma and Brain Neoplasm, run by National Institute of Neurological Disorders and Stroke (NINDS).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median Overall Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01413438, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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