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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Brain & Spine Surgeons of New York.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Abrahams, M.D., Brain & Spine Surgeons of New York
ClinicalTrials.gov Identifier:
NCT01526837
First received: November 5, 2011
Last updated: February 2, 2012
Last verified: February 2012
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Brain & Spine Surgeons of New York:

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

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

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


Estimated Enrollment: 24
Study Start Date: October 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01526837

Contacts
Contact: John Abrahams, MD 914-948-8003 jabrahams@bssny.com
Contact: Jan Strack, RN 914-517-7982 jstrack@bssny.com

Locations
United States, New York
Brain & Spine Surgeons of New York Recruiting
White Plains, New York, United States, 10604
Contact: John Abrahams, M.D.    914-948-3008    jabrahams@bssny.com   
Contact: Jan Strack, RN    914-517-7982    jstrack@bssny.com   
Principal Investigator: John Abrahams, M.D.         
Sponsors and Collaborators
Brain & Spine Surgeons of New York
Investigators
Principal Investigator: John Abrahams, MD Brain & Spine Surgeons of New York
  More Information

No publications provided

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
Study First Received: November 5, 2011
Last Updated: February 2, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014