Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT02438995
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
11 participants
INTERVENTIONAL
2015-05-31
2021-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cetuximab with Radiation Therapy
For subjects receiving radiation therapy, the treatment schedule will consist of a re-irradiation dose of approximately 70 Gy over 6-7 weeks. This experimental treatment arm will add IA Cetuximab administration every three weeks up to 2 doses to this radiation schedule.
Intraarterial Cetxuimab (Erbitux)
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)
Cetuximab Alone
For subjects who are not candidates for re-irradiation, this experimental treatment arm will include only IA Cetuximab administration every three weeks up to 2 doses.
Intraarterial Cetxuimab (Erbitux)
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)
Interventions
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Intraarterial Cetxuimab (Erbitux)
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)
Eligibility Criteria
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Inclusion Criteria
2. Patients with a documented diagnosis of recurrent head and neck squamous cell cancer (squamous cell carcinoma, including nasopharyngeal cancer, or adenoid cystic carcinoma).
Patients must have at least one confirmed and evaluable tumor site.\* The recurrence must have bidimensional measurements by clinical examination or CT/MRI/PET scan. A confirmed recurrence site may also be biopsy-proven
3. Tumor Recurrence which is surgically unresectable
4. Patients must have a Karnofsky performance status ≥70% (or the equivalent ECOG level of 0-2) (see Appendix Performance Status Evaluation) and an expected survival of ≥ three months.
5. 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
6. 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.
7. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.
8. 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.
9. Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.
10. Patients who refuse surgery.
Exclusion Criteria
2. Women of childbearing potential and fertile men will be informed as to the potential risk of procreation 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.
3. 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.
4. Pre-existing cardiac or respiratory disorders
5. Unrelated malignancy within 3 years
6. History of hypersensitivity reactions to other EGFR inhibitors
7. Metastatic disease
8. Less than 6 months from prior Radiation Therapy (Arm 1)
9. Previous exposure to Cetuximab
18 Years
ALL
No
Sponsors
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Northwell Health
OTHER
Responsible Party
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John Boockvar, MD Zucker SOM @Hofstra/Northwell
Professor of Neurosurgery and Otolaryngology/Head and Neck Surgery
Principal Investigators
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John Boockvar, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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Lenox Hill Hospital
New York, New York, United States
Countries
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References
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Tham T, White TG, Chakraborty S, Lall RR, Ortiz R, Langer DJ, Shatzkes D, Filippi CG, Kraus D, Boockvar JA, Costantino PD. Intra-arterial cetuximab for the treatment of recurrent unresectable head and neck squamous cell carcinomadagger. J Exp Ther Oncol. 2016 Nov;11(4):293-301.
Other Identifiers
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15-182
Identifier Type: -
Identifier Source: org_study_id