Super-Selective Intraarterial Intracranial Infusion of Bevacizumab (Avastin) for Glioblastoma Multiforme
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/8/2018 |
| Start Date: | June 2014 |
| End Date: | June 2020 |
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, resulting in median overall survival durations of only 9-12 months for GBM. Initial
therapy consists of surgical resection, external beam radiation or both. Currently, all
patients experience a recurrence after this first-line therapy, so improvements in both
first-line and salvage therapy are critical to enhancing quality-of-life and prolonging
survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can
effectively increase the concentration of drug delivered to the brain while sparing the body
of systemic side effects. This technique threads a tiny catheter through the patient's
femoral artery in the leg, up through the body and neck and into the brain. Once the catheter
reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.
all primary brain tumors in adults. This group of tumors also exhibits the most aggressive
behavior, resulting in median overall survival durations of only 9-12 months for GBM. Initial
therapy consists of surgical resection, external beam radiation or both. Currently, all
patients experience a recurrence after this first-line therapy, so improvements in both
first-line and salvage therapy are critical to enhancing quality-of-life and prolonging
survival. Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can
effectively increase the concentration of drug delivered to the brain while sparing the body
of systemic side effects. This technique threads a tiny catheter through the patient's
femoral artery in the leg, up through the body and neck and into the brain. Once the catheter
reaches the brain, chemotherapy is released to the blood vessels that feed the tumor.
Inclusion Criteria:
- 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 Criteria:
- 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.
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