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

Phase 1

Terminated

• Conditions: Glioblastoma Multiforme
• Interventions: Drug: Avastin

• Registration Number: NCT01526837
• Lead Sponsor: Brain & Spine Surgeons of New York

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted QC: 2012-02-02
• Study First Posted: 2012-02-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bevacizumab (Avastin)	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).

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.	4 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events	12 months	All adverse events will be recorded in the case report form.
Progression Free Survival	12 months	Patients will be followed for survival as well as disease progression for 12 months after treatment.

Trial Locations

Locations (1)

Brain & Spine Surgeons of New York; 🇺🇸 White Plains, New York, United States