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NCT Number: NCT01811498

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lenox Hill Brain Tumor Center

New York, 10065, United States

About this study

The experimental aspects of this experimental plan will include:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab

Drug

Other names: Avastin

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Percent of Participants with 6 Month Progression-Free Survival

    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.

  2. Overall Survival (OS)

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

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

Secondary outcomes

  1. Number of Adverse Events

    Time frame: 30 days post treatment

    The descriptive frequency of subjects experiencing toxicities will be tabulated.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Feinstein Institute for Medical Research

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Mar 14, 2013
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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