Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anaplastic Astrocytoma
- Brain Stem Glioma
- Diffuse Intrinsic Pontine Glioma
- Fibrillary Astrocytoma of Brain
- Glioblastoma Multiforme
- Glioma of Brainstem
- Mixed Oligodendroglioma-Astrocytoma
- Pilomyxoid Astrocytoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 1 years and 21 years
- Gender
- Both males and females
Description
The experimental aspects of this treatment plan will include: 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 fo...
The experimental aspects of this treatment plan will include: 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. 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.
Tracking Information
- NCT #
- NCT01884740
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jeffery Greenfield, MD PhD Weill Medical College of Cornell University
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