Super-Selective Intraarterial Intracranial Infusion of Avastin (Bevacizumab)

Part of paid clinical trials in New York, New York.

Sponsor
Northwell Health
Study ID
NCT00968240
Phase
PHASE1
Status
Completed

Conditions

  • Anaplastic Astrocytoma
  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Super-Selective Intraarterial Intracranial Infusion of BEVACIZUMAB — DRUG
    This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival of patients with relapsed/refractory GBM/AA. Day 0: Intraarterial Avastin single dose (starting at 2mg/kg and up to 10mg/kg) after Mannitol to open the blood brain barrier.

Study Details

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). Superselective Intraarterial Cerebral Infusion (SIACI) is a technique that can effectively increase the concentration of drug delivered to the brain while sparing the body of systemic side effects. One currently used drug called, Bevacizumab (Avastin) has been shown to be active in human brain tumors but its actual CNS penetration is unknown. This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival of patients with relapsed/refractory GBM/AA. By achieving the aims of this study we will determine the toxicity profile and maximum tolerated dose (MTD of SIACI Bevacizumab. We expect that this project will provide important information regarding the utility of SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to our patients in the near future.

Key Dates

First listed
Aug 28, 2009
Start date
Jul 31, 2009
Status verified
Apr 2015
Primary completion
Jan 31, 2014
Completion
Jan 31, 2014

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To determine the safety of superselective intracranial intraarterial infusion of Avastin up to a dose of 10mg/kg IA. [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lenox Hill Brain Tumor CenterNew YorkNew York10075-

Find similar trials in New York, NY

By research site
Lenox Hill Brain Tumor Center· New York, NY

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