Bevacizumab With or Without Surgery for Adult Glioblastomas

NCT01413438 | Withdrawn Phase 2

• 2 other identifiers: 11020411-N-0204
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Glioblastoma; Brain Neoplasm

Keywords

Bevacizumab; Quality of Life; Glioblastoma Multiforme; Neurosurgery; Glioblastoma; GBM; Brain Tumor

Outcome Measures

Primary Outcomes (1)

• Median Overall Survival

  2 years

Secondary Outcomes (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.

  2 years

Interventions

Craniotomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Related Publications (3)

• 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.

  PMID: 20546782 BACKGROUND

• 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.

  PMID: 20212224 BACKGROUND

• 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.

  PMID: 15758009 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• John K Park, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: August 10, 2011
• Study Start: July 15, 2011
• Primary Completion: September 26, 2013
• Study Completion: September 26, 2013
• Last Updated: July 2, 2017

Record last verified: 2013-09-26