Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
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ClinicalTrials.gov Identifier: NCT01386710 |
Recruitment Status :
Suspended
(PI left previous institution study will reopen at new institution.)
First Posted : July 1, 2011
Last Update Posted : October 28, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioblastoma Multiforme Anaplastic Astrocytoma | Drug: Bevacizumab and Carboplatin | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 54 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | May 2023 |
Estimated Study Completion Date : | May 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm 2
Drug: Bevacizumab and Carboplatin
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Drug: Bevacizumab and Carboplatin
Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier Day 28: No biweekly IV Bevacizumab plus Carboplatin treatment If MRI shows progression then repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression Repeat Cycle |
Experimental: Arm 1
Drug: Bevacizumab and Carboplatin
|
Drug: Bevacizumab and Carboplatin
Day 0: Intraarterial Bevacizumab single dose (15mg/kg) plus Intraarterial Carboplatin (150mg/m2) after Mannitol to open the blood brain barrier Day 28: Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until disease progression on MRI scan. If progression occurs, repeat intraarterial Bevacizumab single dose (15mg/kg) plus intraarterial Carboplatin (150mg/m2) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) plus Carboplatin (AUG5) every two weeks thereafter until progression on MRI scan. Repeat Cycle |
- Composite overall response rate [ Time Frame: 6 months ]The composite overall response rate (CORR) will be examined. The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions.
- Six-month progression-free survival (PFS) and overall survival (OS) [ Time Frame: 2 years ]PFS will be measured from the date of the first dose of SIACI Bevacizumab plus Carboplatin to the date of progression. OS will be measured from the date of the first dose of SIACI Bevacizumab plus Carboplatin to the date of death.
- The safety of repeated SIACI of Mannitol, Bevacizumab plus Carboplatin at 15mg/kg and 150mg/m2 respectively. [ Time Frame: 1 month ]The descriptive frequency of subjects experiencing toxicities will also be tabulated. Toxicities will be assessed and graded according to the NCI Common Toxicity Criteria, version 3.0.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01386710
United States, New York | |
Lenox Hill Brain Tumor Center | |
New York, New York, United States, 10075 |
Principal Investigator: | John Boockvar, MD | Lenox Hill Hospital |
Responsible Party: | John Boockvar, MD Zucker SOM @Hofstra/Northwell, MD, Feinstein Institute for Medical Research |
ClinicalTrials.gov Identifier: | NCT01386710 |
Other Study ID Numbers: |
1012011410 |
First Posted: | July 1, 2011 Key Record Dates |
Last Update Posted: | October 28, 2021 |
Last Verified: | October 2021 |
GBM AA AO Brain Tumors |
Malignant Glioblastoma Multiforme Anaplastic Astrocytoma |
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Bevacizumab Carboplatin Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |