Recruiting
Phase 1
Phase 2

Bevacizumab

Sponsor:

Northwell Health

Code:

NCT01269853

Conditions

Glioblastoma Multiforme

Anaplastic Astrocytoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bevacizumab

Bevacizumab

Study Details

Brief summary:

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.

Conditions

Glioblastoma Multiforme

Anaplastic Astrocytoma

Study ID

NCT01269853

Start date

Oct, 2010

Status verified date

May, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older.
  • Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).
  • Patients must have at least one confirmed and evaluable tumor site. A confirmed tumor site is one in which is biopsy-proven.
  • 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:

  • Previous treatment with greater than 2 cycles of Bevacizumab at 10mg/kg (2 IV Infusions).
  • Women who are pregnant or lactating.
  • 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.

Study Design

Enrollment

54 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 2

experimental: Arm 1

Interventions

Bevacizumab

Experimental portion of this proposal:

This trial will have two experimental arms that will be open labeled and non-randomized.

ARM 1 (If the patient has multifocal disease or leptomeningeal disease)

Day 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until disease progression on MRI scan.

If progression occurs, repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression and wait 28 days and then restart Intravenous Bevacizumab (10mg/kg) every two weeks thereafter until progression on MRI scan.

Repeat Cycle

Bevacizumab

ARM 2 (If the patient has no multifocal disease or leptomeningeal disease)

Day 0: Intraarterial Bevacizumab single dose (15mg/kg) after Mannitol to open the blood brain barrier Day 28: No biweekly IV Bevacizumab treatment

If MRI shows progression then repeat Intraarterial Bevacizumab single dose (15mg/kg) to area of progression Repeat Cycle

Primary outcome measure

  • Composite overall response rate (CORR) [ Time Frame: 6 months ]
  • Progression-free survival (PFS) and overall survival (OS) [ Time Frame: 6 month ]

Central Contacts and Locations

Central contacts

Locations

Lenox Hill Brain Tumor Center

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

John Boockvar, MD

More Information

Sponsor

Northwell Health

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-01.