Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02438995
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
John Boockvar, MD Zucker SOM @Hofstra/Northwell, Northwell Health

Brief Summary:
This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC).

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Carcinoma, Squamous Cell of Head and Neck Drug: Intraarterial Cetxuimab (Erbitux) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of 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
Study Start Date : May 2015
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Arm Intervention/treatment
Experimental: 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.
Drug: Intraarterial Cetxuimab (Erbitux)
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)

Experimental: 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.
Drug: Intraarterial Cetxuimab (Erbitux)
Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)




Primary Outcome Measures :
  1. The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab. [ Time Frame: 30 days ]
  2. Descriptive frequency of subjects experiencing toxicities. [ Time Frame: 30 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients of ≥18 years of age.
  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:

  1. Women who are pregnant or lactating.
  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

Information from the National Library of Medicine

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): NCT02438995


Contacts
Layout table for location contacts
Contact: John Boockvar, MD 212-434-3900 jboockvar@nshs.edu
Contact: Tamika Wong, MPH 212-434-4836 twong4@nshs.edu

Locations
Layout table for location information
United States, New York
Lenox Hill Hospital Recruiting
New York, New York, United States, 10028
Contact: John Boockvar, MD    212-434-3900    jboockvar@nshs.edu   
Contact: Tamika Wong, MPH    212-434-4836    twong4@nshs.edu   
Principal Investigator: John Boockvar, MD         
Principal Investigator: Peter Costantino, MD         
Principal Investigator: Dennis Kraus, MD         
Sub-Investigator: David Langer, MD         
Sub-Investigator: Rafael Ortiz, MD         
Sub-Investigator: Keith Brunckhorst, MD         
Sub-Investigator: Jed Pollack, MD         
Sub-Investigator: Anuj Goenka, MD         
Sub-Investigator: Sherese Fralin, NP         
Sub-Investigator: Ashley Ray, NP         
Sub-Investigator: Tamika Wong, MPH         
Sub-Investigator: Tristan Tham, MD         
Sponsors and Collaborators
Northwell Health
Investigators
Layout table for investigator information
Principal Investigator: John Boockvar, MD Northwell Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: John Boockvar, MD Zucker SOM @Hofstra/Northwell, Professor of Neurosurgery and Otolaryngology/Head and Neck Surgery, Northwell Health
ClinicalTrials.gov Identifier: NCT02438995    
Other Study ID Numbers: 15-182
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents