- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02861898
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
Phase I/II Trial of Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: John Boockvar, MD
- Phone Number: 212-434-4836
- Email: jboockvar@northwell.edu
Study Contact Backup
- Name: Tamika Wong, MPH
- Phone Number: 212-434-4836
- Email: twong4@northwell.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10075
- Recruiting
- Lenox Hill Brain Tumor Center
-
Contact:
- Tamika Wong, MPH
- Phone Number: 212-434-4836
- Email: twong4@northwell.edu
-
Contact:
- John Boockvar, MD
- Phone Number: 212-434-3900
- Email: jboockvar@northwell.edu
-
Sub-Investigator:
- David Langer, MD
-
Sub-Investigator:
- Christopher Filippi, MD
-
Sub-Investigator:
- Tamika Wong, MPH
-
Sub-Investigator:
- Rafael Ortiz, MD
-
Sub-Investigator:
- Ashley Ray, NP
-
Sub-Investigator:
- Sherese Fralin, NP
-
Sub-Investigator:
- Anuj Goenka, MD
-
Sub-Investigator:
- Jed Pollack, MD
-
Sub-Investigator:
- Karissa Tan, NP
-
Sub-Investigator:
- Shamik Chakraborty, MD
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Principal Investigator:
- John Boockvar, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female patients of ≥18 years of age.
- Patients with a documented histologic diagnosis of newly diagnosed glioblastoma multiforme (GBM)
- Patients with pathology confirmed histologic EGFR overexpression
Patients must have at least one confirmed and evaluable tumor site.∗
*A confirmed tumor site is one in which is biopsy-proven. NOTE: Radiographic procedures (e.g., Gd-enhanced MRI or CT scans) documenting existing lesions must have been performed within two weeks of treatment on this research study.
- Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) and an expected survival of ≥ three months.
- No chemotherapy for two weeks prior to treatment under this research protocol and no external beam radiation for eight weeks prior to treatment under this research protocol.
- Patients must have adequate hematologic reserve with WBC≥3000/mm3, absolute neutrophils ≥1500/mm3 and platelets ≥100,000/ mm3. Patients who are on Coumadin must have a platelet count of ≥150,000/ mm3
- Pre-enrollment chemistry parameters must show: bilirubin<1.5X the institutional upper limit of normal (IUNL); AST or ALT<2.5X IUNL and creatinine<1.5X IUNL.
- Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
- Patients must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study.
- Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potential risk of conception while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring
- Patients with radiological evidence of leptomeningeal disease.
- Patients with history of allergic reaction to CTX
- Patients who initiated or completed chemo/RT
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Overall Survival (OS)
Time Frame: 2 years
|
OS will be calculated as the time from treatment initiation to the date of death.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Glioblastoma
- Brain Neoplasms
- Physiological Effects of Drugs
- Antineoplastic Agents
- Natriuretic Agents
- Antineoplastic Agents, Immunological
- Diuretics, Osmotic
- Diuretics
- Mannitol
- Cetuximab
Other Study ID Numbers
- HS16-0257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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