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

• Sponsor: Northwell Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02438995
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 73
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 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
• Actual Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 1, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab. [30 days]

2. Descriptive frequency of subjects experiencing toxicities. [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Tumor Recurrence which is surgically unresectable

2. 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.

3. 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

4. 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.

5. Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5X the IUNL.

6. 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.

7. Patients must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening.

8. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lenox Hill Hospital	New York	New York	United States	10028

Sponsors and Collaborators

• Northwell Health

Investigators

• Principal Investigator: John Boockvar, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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
• Last Update Posted: Nov 3, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Cetuximab

Study Results

No Results Posted as of Nov 3, 2021