Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22

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

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01884740
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Anaplastic Astrocytoma
  • Brain Stem Glioma
  • Diffuse Intrinsic Pontine Glioma
  • Fibrillary Astrocytoma of Brain
  • Glioblastoma Multiforme
  • Glioma of Brainstem
  • Mixed Oligodendroglioma-Astrocytoma
  • Pilomyxoid Astrocytoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • SIACI of Erbitux and Bevacizumab — DRUG
    Subjects will receive a single intra-arterial dose of Cetuximab (200 mg/m\^2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).

Study Details

Central nervous system (CNS) malignancies are the second most common malignancy and the most common solid tumor of childhood, including adolescence. Annually in the United States, approximately 2,200 children are diagnosed with CNS malignancy and rates appear to be increasing. CNS tumors are the leading cause of death from solid tumors in children. Survival duration after diagnosis in children is highly variable depending in part on age at diagnosis, location of tumor, and extent of resection; however, most children with high grade glioma die within 3 years of diagnosis. All patients with high grade glioma 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). We have shown in previous phase I trials that a single Superselective Intra-arterial Cerebral Infusion (SIACI) of Cetuximab and/or Bevacizumab is safe for the treatment of recurrent glioblastoma multiforme (GBM) in adults, and we are currently evaluating the efficacy of this treatment. Therefore, this phase I/II clinical research trial is an extension of that trial in that we seek to test the hypothesis that intra-arterial Cetuximab and Bevacizumab is safe and effective in the treatment of relapsed/refractory glioma in patients \<22 years of age. We expect that this project will provide important information regarding the utility of SIACI Cetuximab and Bevacizumab therapy for malignant glioma in patients \<22 years of age and may alter the way these drugs are delivered to our patients in the near future.

Key Dates

First listed
Jun 24, 2013
Start date
Jun 30, 2013
Status verified
Jul 2022
Primary completion
Oct 31, 2018
Completion
Oct 31, 2018

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SIACI of Erbitux and Bevacizumab
    Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 mg/m\^2) and Bevacizumab (15 mg/kg)

Primary Outcome Measure

Median Overall Survival (OS) [ Time Frame: 2 Years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical College/New York Presbyterian HospitalNew YorkNew York10001-

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Weill Cornell Medical College/New York Presbyterian Hospital· New York, NY

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