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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01526837
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Brain & Spine Surgeons of New York
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	John Abrahams, MDJan Strack
Principal Investigator Affiliation	Brain & Spine Surgeons of New YorkBSSNY
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Terminated
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma Multiforme

Arms & Interventions

Arms

Experimental: 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).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

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

Status

Address

Brain & Spine Surgeons of New York

White Plains, New York, 10604

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