Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
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|ClinicalTrials.gov Identifier: NCT02861898|
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : May 17, 2019
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol).
This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Brain Cancer Brain Neoplasm Brain Tumor Brain Neoplasm, Malignant EGFR Gene Overexpression GBM||Drug: Intra-arterial Cetuximab Drug: Intra-arterial Mannitol||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Intra-arterial Cetuximab after BBBD
Mannitol 20% 12.5ml over two minutes for Blood Brain Barrier (BBB) disruption followed by CTX administered intra-arterially for three doses at a dose of 250mg/m2
Drug: Intra-arterial Cetuximab
Drug: Intra-arterial Mannitol
- Progression Free Survival (PFS) [ Time Frame: 6 months ]The 6-month PFS will be estimated by calculating the proportion of patients who are alive at 6 months from treatment commencement and are progression-free.
- Overall Survival (OS) [ Time Frame: 2 years ]OS will be calculated as the time from treatment initiation to the date of death.
- Composite overall response rate (CORR) through the Response Assessment in Neuro-Oncology (RANO) [ Time Frame: 6 months ]Subjects will be classified according to the RANO criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
- Toxicities graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03 [ Time Frame: 6 months ]Toxicities will be tabulated and graded according to the NCI Common Toxicity Criteria (CTCAE) version 4.03
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): NCT02861898
|Contact: John Boockvar, MDfirstname.lastname@example.org|
|Contact: Tamika Wong, MPHemail@example.com|
|United States, New York|
|Lenox Hill Brain Tumor Center||Recruiting|
|New York, New York, United States, 10075|
|Contact: John Boockvar, MD 212-434-3900 firstname.lastname@example.org|
|Contact: Tamika Wong, MPH 212-434-4836 email@example.com|
|Principal Investigator: John Boockvar, MD|
|Sub-Investigator: David Langer, MD|
|Sub-Investigator: Rafael Ortiz, MD|
|Sub-Investigator: Jed Pollack, MD|
|Sub-Investigator: Anuj Goenka, MD|
|Sub-Investigator: Christopher Filippi, MD|
|Sub-Investigator: Sherese Fralin, NP|
|Sub-Investigator: Ashley Ray, NP|
|Sub-Investigator: Tamika Wong, MPH|
|Sub-Investigator: Karissa Tan, NP|
|Sub-Investigator: Shamik Chakraborty, MD|