- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02800486
Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
November 7, 2023 updated by: John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health
Phase II Trial of Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory Glioblastoma Multiforme, Anaplastic Astrocytoma, and Anaplastic Oligoastrocytoma
Primary 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 of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis.
Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors.
The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
37
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tamika Wong, MPH
- Phone Number: 212-434-4836
- Email: twong4@northwell.edu
Study Contact Backup
- Name: John Boockvar, MD
- Phone Number: 212-434-3900
- Email: jboockvar@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:
- 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:
- Alexis Demopoulos, MD
-
Sub-Investigator:
- Jed Pollack, MD
-
Sub-Investigator:
- Karissa Tan, NP
-
Principal Investigator:
- John Boockvar, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female patients of ≥18 years of age
- Patients with a documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA) or anaplastic oligoastrocytoma (AOA)
- 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
- Patients must have a Karnofsky performance status ≥60% 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 of the potential unknown 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 completed chemo/RT less than 6 months prior to enrollment
- Patients who have not failed standard Stupp protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 with Re-Irradiation
Mannitol 20% 12.5ml over two minutes for blood brain barrier (BBB) disruption followed by Cetuximab administered intra-arterially for three doses at a dose of 250 mg/m2 combined with hypofractionated re-irradiation
|
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 |
---|---|---|
Composite overall response rate (CORR) through the Response Evaluation Criteria In Solid Tumors (RECIST)
Time Frame: 6 months
|
Subjects will be classified according to the RECIST criteria, which is a composite of MRI changes, clinical response and changes in steroid use.
|
6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: John Boockvar, MD, Northwell Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2026
Study Registration Dates
First Submitted
May 27, 2016
First Submitted That Met QC Criteria
June 14, 2016
First Posted (Estimated)
June 15, 2016
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Glioblastoma
- Brain Neoplasms
- Astrocytoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Natriuretic Agents
- Antineoplastic Agents, Immunological
- Diuretics, Osmotic
- Diuretics
- Mannitol
- Cetuximab
Other Study ID Numbers
- HS16-0181
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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