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

NCT ID: NCT01526837

Last Updated: 2017-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-01-31

Brief Summary

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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

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Conditions

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Glioblastoma Multiforme

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Avastin

Intervention Type DRUG

Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain & Spine Surgeons of New York

OTHER

Sponsor Role lead

Responsible Party

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John Abrahams, M.D.

Associate Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Abrahams, MD

Role: PRINCIPAL_INVESTIGATOR

Brain & Spine Surgeons of New York

Jan Strack

Role: STUDY_DIRECTOR

BSSNY

Locations

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Brain & Spine Surgeons of New York

White Plains, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BSSNY-B-001

Identifier Type: -

Identifier Source: org_study_id

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