NCT01526837TerminatedPhase 1
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
Brain & Spine Surgeons of New York1 site in 1 country1 target enrollmentStarted: October 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recurrent Glioblastoma
- •At least 12 weeks expected survival (KPS >60)
- •18 years of age or older
- •Able and willing to participate
Exclusion Criteria
- •Any prior diagnosis of any other cancer or other concurrent malignancy.
- •Planned use or current use of other investigation therapy.
- •Systemic autoimmune disease
- •HIV positive
- •Concurrent life threatening disease
- •Impaired organ function
- •Active infection
- •Inadequately controlled hypertension
- •Congestive heart failure
- •Myocardial infection/unstable angina within 6 months
- •Stroke within 6 months
- •Pheripheral vascular disease
- •History of abdominal fistula/gastrointestinal performation
- •Non-healing wound
- •Coagulation disease
- •Known allergy to study treatments
- •Pregnant or lactating
Arms & Interventions
bevacizumab (Avastin)
Experimental
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).
Intervention: Avastin (Drug)
Outcomes
Primary Outcomes
Maximum Tolerated Dose of bevacizumab (Avastin) following local administration.
Time Frame: 4 weeks
Secondary Outcomes
- Number of Adverse Events(12 months)
- Progression Free Survival(12 months)
Investigators
John Abrahams, M.D.
Associate Professor of Neurosurgery
Brain & Spine Surgeons of New York
Study Sites (1)
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