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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01526837
Other study ID # BSSNY-B-001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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