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

Sponsor
Brain & Spine Surgeons of New York (Other)
Overall Status
Terminated
CT.gov ID
NCT01526837
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
3
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
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
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jan 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Maximum Tolerated Dose of bevacizumab (Avastin) following local administration. [4 weeks]

Secondary Outcome Measures

  1. Number of Adverse Events [12 months]

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

  2. Progression Free Survival [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:

  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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Abrahams, M.D., Associate Professor of Neurosurgery, Brain & Spine Surgeons of New York
ClinicalTrials.gov Identifier:
NCT01526837
Other Study ID Numbers:
  • BSSNY-B-001
First Posted:
Feb 6, 2012
Last Update Posted:
Jul 12, 2017
Last Verified:
Jul 1, 2017
Keywords provided by John Abrahams, M.D., Associate Professor of Neurosurgery, Brain & Spine Surgeons of New York
Brain tumor
GBM
Brain cancer
Additional relevant MeSH terms:
Glioblastoma
Recurrence
Bevacizumab

Study Results

No Results Posted as of Jul 12, 2017