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

This study has been terminated.
(Investigators decision)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526837
First Posted: February 6, 2012
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Abrahams, M.D., Brain & Spine Surgeons of New York
  Purpose
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.

Condition Intervention Phase
Glioblastoma Multiforme Drug: Avastin Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Dose-Escalating Phase I Study for Safety and Tolerability of Bevacizumab in Collagen Delivery Vehicle Administered Into the Tumor Resection Cavity in Subjects With Glioblastoma Multiforme at First Recurrence

Resource links provided by NLM:


Further study details as provided by John Abrahams, M.D., Brain & Spine Surgeons of New York:

Primary Outcome Measures:
  • Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Number of Adverse Events [ Time Frame: 12 months ]
    All adverse events will be recorded in the case report form.

  • Progression Free Survival [ Time Frame: 12 months ]
    Patients will be followed for survival as well as disease progression for 12 months after treatment.


Enrollment: 1
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01526837


Locations
United States, New York
Brain & Spine Surgeons of New York
White Plains, New York, United States, 10604
Sponsors and Collaborators
Brain & Spine Surgeons of New York
Investigators
Principal Investigator: John Abrahams, MD Brain & Spine Surgeons of New York
Study Director: Jan Strack BSSNY
  More Information

Responsible Party: John Abrahams, M.D., Associate Professor of Neurosurgery, Brain & Spine Surgeons of New York
ClinicalTrials.gov Identifier: NCT01526837     History of Changes
Other Study ID Numbers: BSSNY-B-001
First Submitted: November 5, 2011
First Posted: February 6, 2012
Last Update Posted: July 12, 2017
Last Verified: July 2017

Keywords provided by John Abrahams, M.D., Brain & Spine Surgeons of New York:
Brain tumor
GBM
Brain cancer

Additional relevant MeSH terms:
Glioblastoma
Recurrence
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents