Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
Status: | Suspended |
---|---|
Conditions: | Brain Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/23/2019 |
Start Date: | September 2011 |
End Date: | January 2022 |
Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory Glioblastoma Multiforme And Anaplastic Astrocytoma
The high-grade malignant brain tumors, glioblastoma multiforme (GBM) and anaplastic
astrocytoma (AA), 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, and 3-4 years for AA. Initial therapy consists of
either surgical resection, external beam radiation or both. All patients experience a
recurrence after first-line therapy, so improvements in both first-line and salvage therapy
are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently
used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators
have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral
Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of
recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that
trial in that the investigators seek to test the hypothesis that repeated dosing of
intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant
glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will
further improve the treatment response. By achieving the aims of this study the investigators
will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined
with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression
free and overall survival. The investigators expect that this project will provide important
information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma,
and may alter the way these drugs are delivered to the investigators patients in the near
future.
astrocytoma (AA), 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, and 3-4 years for AA. Initial therapy consists of
either surgical resection, external beam radiation or both. All patients experience a
recurrence after first-line therapy, so improvements in both first-line and salvage therapy
are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently
used intravenous (IV) therapies even cross the blood brain barrier (BBB). The investigators
have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral
Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of
recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that
trial in that the investigators seek to test the hypothesis that repeated dosing of
intra-arterial Bevacizumab is safe and effective in the treatment of recurrent malignant
glioma. Additionally the investigators will analyze if a combination with IA Carboplatin will
further improve the treatment response. By achieving the aims of this study the investigators
will also determine if IV therapy with Bevacizumab with IV Carboplatin should be combined
with repeated selected intra-arterial Bevacizumab plus Carboplatin to improve progression
free and overall survival. The investigators expect that this project will provide important
information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma,
and may alter the way these drugs are delivered to the investigators patients in the near
future.
Inclusion Criteria:
- 18 years of age or older.
- Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme
(GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).
- Circumscribed tumor recurrence with less than 3.5 cm greatest diameter
- Patients with histologically confirmed low-grade brain tumor relapse with an enhancing
tumor on MRI will be evaluated for toxicity only.
- Patients must have at least one confirmed and evaluable tumor site.
- Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of
0-2)
- Patients must agree to use a medically effective method of contraception during and
for a period of three months after the treatment period.
Exclusion Criteria:
- Women who are pregnant or lactating.
- 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.
- Low GFR or history of hepatorenal syndrome
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