Clinical Trial: NCT01811498 - My Cancer Genome

NCT01811498

Description:

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, resulting in median overall survival of only 9-12 months. 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). We 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 we seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this study we will also determine if repeated intra-arterial Bevacizumab improves progression free and overall survival in newly diagnosed patients. We 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 our patients in the near future.

Related Conditions:

Conventional Glioblastoma Multiforme

Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT01811498

Trial Eligibility

Document

Title

Brief Title: Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
Official Title: Phase I/II Trial of Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed Glioblastoma Multiforme

Clinical Trial IDs

ORG STUDY ID: 14-352
NCT ID: NCT01811498

Conditions

Glioblastoma Multiforme
Brain Tumor

Interventions

Drug	Synonyms	Arms
Bevacizumab	Avastin	SIACI of Bevacizumab

Purpose

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 order to disrupt the blood brain barrier.
           This technique has been used in several thousand subjects in previous studies for the IA
           delivery of chemotherapy for malignant glioma.

        2. Subjects will then be treated with repeated intraarterial delivery (SIACI) of
           Bevacizumab. Each subject will receive one dose of IA Bevacizumab on day 30, followed by
           chemoradiation. SIACI of Bevacizumab will be repeated every three months for a total of
           3 infusions.

Trial Arms

Name	Type	Description	Interventions
SIACI of Bevacizumab	Experimental	Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab	Bevacizumab

Eligibility Criteria

        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.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Composite overall response rate (CORR)
Time Frame:	6 month
Safety Issue:
Description:	Composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO)

Secondary Outcome Measures

Measure:	Toxicities
Time Frame:	1 month ongoing
Safety Issue:
Description:	The descriptive frequency of subjects experiencing toxicities will be tabulated.

Details

Phase:	Phase 1/Phase 2
Primary Purpose:	Interventional
Overall Status:	Active, not recruiting
Lead Sponsor:	Northwell Health

Last Updated

March 3, 2021

Clinical Trials /

Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM