Phase I/II Trial Of Super-Selective Intraarterial Infusion Of Erbitux (Cetuximab) And Avastin (Bevacizumab)For Treatment Of Relapsed/Refractory Intracranial Glioma In Patients Under 22 Years Of Age
The experimental aspects of this treatment plan will include:
1. Subjects will first be treated with Mannitol prior to chemotherapy infusion (Mannitol
25%; 10 mL over 2 minutes) in order to disrupt the blood brain barrier. This technique
has been used in several thousand patients in previous studies for the IA delivery of
chemotherapy for malignant glioma. We have used this without complication in our
patients from our Phase I protocols as well.
2. To treat patients <22 years of age with recurring or relapsing glioma with a single
intraarterial delivery (SIACI) of Cetuximab and Bevacizumab. Our Phase I trials have
demonstrated the safety of SIACI delivery of these drugs in adults. This trial will
focus on the safety and efficacy in patients <22 years of age.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities
The descriptive frequency of subjects experiencing toxicities will be tabulated. Toxicities will be assessed and graded according to the NCI Common Toxicity Criteria, version 4.0. Exact 95% confidence intervals around the toxicity proportions will be calculated to assess the precision of the obtained estimates.
2 Years
Yes
Jeffery Greenfield, MD PhD
Principal Investigator
Weill Medical College of Cornell University
United States: Institutional Review Board
1202012214
NCT01884740
June 2013
January 2018
Name | Location |
---|---|
Weill Cornell Medical College/New York Presbyterian Hospital | New York, New York 10021 |