Status:
COMPLETED
Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Feinstein Institute for Medical Research
Conditions:
Glioblastoma Multiforme
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resu...
Detailed Description
The experimental aspects of this experimental plan will include: 1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol 20%; delivered IA, 12.5 mL over 2 minutes) in...
Eligibility Criteria
Inclusion
- Criteria for Inclusion:
- Male or female patients of ≥18 years of age.
- Patients with documented histologic diagnosis of glioblastoma multiforme (newly diagnosed)
- Patients must have at least one confirmed and evaluable tumor site.∗
- \*A confirmed tumor site is one which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within three weeks of treatment on this research study.
- Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Criteria for Exclusion:
- Previous treatment with Bevacizumab.
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men who decline to use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring.
Exclusion
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01811498
Start Date
February 1 2013
End Date
October 1 2021
Last Update
January 30 2024
Active Locations (1)
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1
Lenox Hill Brain Tumor Center
New York, New York, United States, 10065