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Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory Glioblastoma Multiforme And Anaplastic Astrocytoma


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

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Trial Information

Phase I/II Trial Of Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory Glioblastoma Multiforme And Anaplastic Astrocytoma


Inclusion Criteria:



- 18 years of age or older.

- Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme
(GBM), anaplastic astrocytoma (AA) or anaplastic mixed oligoastrocytoma (AOA).

- Circumscribed tumor recurrence with less than 3.5 cm greatest diameter

- Patients with histologically confirmed low-grade brain tumor relapse with an
enhancing tumor on MRI will be evaluated for toxicity only.

- Patients must have at least one confirmed and evaluable tumor site.

- 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:

- Women who are pregnant or lactating.

- 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.

- Low GFR or history of hepatorenal syndrome

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite overall response rate

Outcome Description:

The composite overall response rate (CORR) will be examined. The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions.

Outcome Time Frame:

6 months

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:

1012011410

NCT ID:

NCT01386710

Start Date:

September 2011

Completion Date:

Related Keywords:

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

Name

Location

Weill Cornell Medical College New York, New York  10021