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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

Yes

Principal Investigator

John Abrahams, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brain & Spine Surgeons of New York

Authority:

United States: Institutional Review Board

Study ID:

BSSNY-B-001

NCT ID:

NCT01526837

Start Date:

October 2011

Completion Date:

October 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Brain tumor
  • GBM
  • Brain cancer
  • Glioblastoma
  • Recurrence

Name

Location

Brain & Spine Surgeons of New York White Plains, New York  10604