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

NCT01811498 | Completed Phase 1 Results DMC

• 1 other identifier: 14-352
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme; Brain Tumor

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS)

  PFS was defined from the date of the first dose of SIACI Bevacizumab until first documentation of disease pro- gression, or death from any cause, whichever occurred first.

  Percent of Participants with 6 Month Progression-Free Survival

• Overall Survival (OS)

  Overall Survival was defined from the date of the first dose of SIACI Bevacizumab until death from any cause.

  8 months, and until death of any cause, up to approximately 8 years

Secondary Outcomes (1)

• Number of Adverse Events

  30 days post treatment

Study Arms (1)

SIACI of Bevacizumab

EXPERIMENTAL

Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Also known as: Avastin

SIACI of Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• Feinstein Institute for Medical Research: collaborator

Study Sites (1)

Lenox Hill Brain Tumor Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John Boockvar, MD
• Organization: Northwell Health

jboockvar@northwell.edu

212-434-3900

Study Officials

• John Boockvar, MD

  Feinstein Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 14, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Locations

US (1)