Intraarterial Infusion Of Erbitux and Bevacizumab For Relapsed/Refractory Intracranial Glioma In Patients Under 22
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01884740|
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : January 30, 2018
|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 2019|
|Estimated Study Completion Date :||January 2019|
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).
- Toxicities [ Time Frame: 2 Years ]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.
- 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. We will define "evaluable" patients as patients who met eligibility requirements and have initiated therapy.
- 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.
- 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|
|Contact: Samantha Buiemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Melissa Ricketts 212-746-7373 email@example.com|
|Sub-Investigator: Mark Souweidane, MD|
|Sub-Investigator: Y. Pierre Gobin, MD|
|Sub-Investigator: Athos Patsalides, MD|
|Sub-Investigator: Paul Christos, Dr.P.H., M.S|
|Sub-Investigator: Heather McCrea, MD PhD|
|Sub-Investigator: Kaleb Yohay, MD|
|Sub-Investigator: Maria Rust, PNP|
|Principal Investigator:||Jeffery Greenfield, MD PhD||Weill Medical College of Cornell University|