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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

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


The experimental aspects of this experimental plan will include:

1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol
25%; delivered IA, 10 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.

2. 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.


Inclusion Criteria:



- Male or female subjects greater than or equal to 18 years of age. Subjects with
documented histologic diagnosis of glioblastoma multiforme (newly diagnosed) Subjects
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. Subjects must have a Karnofsky performance status
of at least 70% (or the equivalent ECOG level of 0-2) and an expected survival of at
least three months. Subjects 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.

Exclusion Criteria:

- 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. Subjects 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Six-month progression-free survival (PFS)

Outcome Description:

Six-month progression-free survival (PFS)and overall survival (OS) will be assessed by Kaplan-Meier survival analysis, assuming adequate follow-up time. PFS will be measured from the date of the first dose of SIACI Bevacizumab to the date of progression.

Outcome Time Frame:

6 month

Safety Issue:

Yes

Principal Investigator

John Boockvar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

1205012355

NCT ID:

NCT01811498

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location

Weill Cornell Medical CollegeNew York, New York  10021