Status:
UNKNOWN
Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
Lead Sponsor:
Global Neurosciences Institute
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The high-grade malignant brain tumor glioblastoma multiforme (GBM) comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulti...
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of GBM
- Grade IV GBM tumors that have recurred after total resection
- Age \> 18 years
- At least four weeks following any recent surgery
- Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥ three months.
- No IV chemotherapy for three weeks prior to treatment under this research protocol and no external beam radiation for four weeks prior to treatment under this research protocol.
- Patients must have adequate hematologic reserve
- Pre-enrollment coagulation parameters (PT and PTT) must be adequate.
- 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.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Exclusion
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02285959
Start Date
June 1 2014
End Date
June 1 2025
Last Update
August 10 2022
Active Locations (1)
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1
Philadelphia, Pennsylvania, United States