Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22
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|ClinicalTrials.gov Identifier: NCT01884740|
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Fibrillary Astrocytoma of Brain Glioma of Brainstem Anaplastic Astrocytoma Pilomyxoid Astrocytoma Mixed Oligodendroglioma-Astrocytoma Brain Stem Glioma Diffuse Intrinsic Pontine Glioma||Drug: SIACI of Erbitux and Bevacizumab||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2025|
|Estimated Study Completion Date :||January 2025|
Experimental: SIACI of Erbitux and Bevacizumab
Superselective Intraarterial Cerebral Infusion (SIACI) of Erbitux (200 m/m2) and Bevacizumab (15 mg/kg)
Drug: SIACI of Erbitux and Bevacizumab
Subjects will receive a single intra-arterial dose of Cetuximab (200 m/m2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
- Composite Overall Response Rate (CORR) [ Time Frame: 6 Months ]The overall response proportion along with a 95% confidence interval will be estimated via binomial proportions. The investigator will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.
- Number of treatment emergent adverse events [ Time Frame: 2 Years ]All treatment emergent adverse events will be assessed and graded according to Common Terminology Criteria for Adverse Events (CTCAE)v. 4.0 terminology for severity, duration, and relationship to research protocol treatment.
- Median Progression-free survival (PFS) [ Time Frame: 2 Years ]PFS 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 Cetuximab/Avastin to the date of progression.
- Median Overall Survival (OS) [ Time Frame: 2 Years ]Overall Survival (OS) will be measured from the date of the first dose of SIACI Cetuximab/Avastin to the date of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884740
|Contact: Jeffrey Greenfield, MD PhDfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Medical College/New York Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10001|
|Contact: Jeffrey Greenfield, MD PhD 212-746-2363 email@example.com|
|Principal Investigator: Jeffrey Greenfield, MD|
|Principal Investigator:||Jeffery Greenfield, MD PhD||Weill Medical College of Cornell University|