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

Glioblastoma Multiforme Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01526837
• Other study ID #: BSSNY-B-001
• Status: Terminated
• Phase: Phase 1
• First received: November 5, 2011
• Last updated: July 11, 2017
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2017
• Source: Brain & Spine Surgeons of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme
• Recurrence

Intervention

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.

Locations

Country	Name	City	State
United States	Brain & Spine Surgeons of New York	White Plains	New York

Sponsors (1)

Lead Sponsor	Collaborator
Brain & Spine Surgeons of New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.		4 weeks
Secondary	Number of Adverse Events	All adverse events will be recorded in the case report form.	12 months
Secondary	Progression Free Survival	Patients will be followed for survival as well as disease progression for 12 months after treatment.	12 months