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TerminatedNCT01526837Updated Jul 12, 2017

Bevacizumab (Avastin) Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence

A Phase 1 interventional study of Avastin in Glioblastoma Multiforme, sponsored by Brain & Spine Surgeons of New York. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-12.

Sponsored by Brain & Spine Surgeons of New York · Phase 1, Interventional, and Treatment

Why this study was terminated
Investigators decision
Phase
Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

This is a phase 1b study for safety and tolerability of bevacizumab(Avastin)administered into the tumor resection cavity in subjects with Glioblastoma Multiforme (GBM) at first recurrence.

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Conditions studied

  • Glioblastoma Multiforme

Keywords

  • Brain tumor
  • GBM
  • Brain cancer
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 449 are open to participants now.

This study's enrollment of 1 is below the median of 36 across 1,617 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

This is the only study on the registry with Brain & Spine Surgeons of New York as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Recurrent Glioblastoma
  2. At least 12 weeks expected survival (KPS >60)
  3. 18 years of age or older
  4. Able and willing to participate

Exclusion criteria

Exclusion Criteria:

  1. Any prior diagnosis of any other cancer or other concurrent malignancy.
  2. Planned use or current use of other investigation therapy.
  3. Systemic autoimmune disease
  4. HIV positive
  5. Concurrent life threatening disease
  6. Impaired organ function
  7. Active infection
  8. Inadequately controlled hypertension
  9. Congestive heart failure
  10. Myocardial infection/unstable angina within 6 months
  11. Stroke within 6 months
  12. Pheripheral vascular disease
  13. History of abdominal fistula/gastrointestinal performation
  14. Non-healing wound
  15. Coagulation disease
  16. Known allergy to study treatments
  17. Pregnant or lactating
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    bevacizumab (Avastin)

    Open-label, dose-escalating study conducted in cohorts of 1-3 patients treated at increasing doses of bevacizumab in the dose range of 1-25mg/Ml. A maximum of 24 subjects will be treated in this study (up to 8 cohorts of 3 subjects).

    Drug: Avastin

Interventions

  • DrugAvastin

    Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.

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What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.

    Time frame: 4 weeks

Secondary outcomes

  1. Number of Adverse Events

    All adverse events will be recorded in the case report form.

    Time frame: 12 months

  2. Progression Free Survival

    Patients will be followed for survival as well as disease progression for 12 months after treatment.

    Time frame: 12 months

07

Study locations

1 site
  • Brain & Spine Surgeons of New York
    White Plains, New York 10604, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01526837
Lead sponsor
Brain & Spine Surgeons of New York
Responsible party
John Abrahams, M.D. (Associate Professor of Neurosurgery, Brain & Spine Surgeons of New York) — Principal investigator
First posted
Feb 6, 2012
Start date
Oct 2011
Primary completion
Jan 2012
Completion
Jan 2012
Last update
Jul 12, 2017

Study contacts

John Abrahams, MD
principal investigator · Brain & Spine Surgeons of New York
Jan Strack
study director · BSSNY

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.

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