RECRUITING

Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 Super-selective 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 intraarterial Bevacizumab is safe and effective in the treatment of recurrent malignant glioma. By achieving the aims of this study the investigators will also determine if IV therapy with Bevacizumab should be combined with repeated selected intraarterial Bevacizumab 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 patients in the near future.

Official Title

Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab (Avastin) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma.

Quick Facts

Study Start:2010-10
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01269853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older.
  2. * Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).
  3. * Patients must have at least one confirmed and evaluable tumor site. A confirmed tumor site is one in which is biopsy-proven.
  4. * Patients must have a Karnofsky performance status 70% (or the equivalent ECOG level of 0-2).
  5. * Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period.
  1. * Previous treatment with greater than 2 cycles of Bevacizumab at 10mg/kg (2 IV Infusions).
  2. * Women who are pregnant or lactating.
  3. * Patients with significant inter-current 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.

Contacts and Locations

Study Contact

John Boockvar, MD
CONTACT
212-434-3905
jboockvar@nshs.edu
Tamika Wong, MPH
CONTACT
212-434-4836
twong4@nshs.edu

Principal Investigator

John Boockvar, MD
PRINCIPAL_INVESTIGATOR
Feinstein Institute for Medical Research

Study Locations (Sites)

Lenox Hill Brain Tumor Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • John Boockvar, MD, PRINCIPAL_INVESTIGATOR, Feinstein Institute for Medical Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2010-10
Study Completion Date2026-10

Study Record Updates

Study Start Date2010-10
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • GBM
  • AA
  • AO
  • Brain
  • Tumors
  • Malignant
  • Glioblastoma
  • Multiforme
  • Anaplastic
  • Astrocytoma

Additional Relevant MeSH Terms

  • Glioblastoma Multiforme
  • Anaplastic Astrocytoma