Clinical trial NCT02438995: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Carcinoma, Squamous Cell
Carcinoma, Squamous Cell of Head and Neck
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: The maximum tolerated dose (MTD) of superselective intraarterial Cetuximab.
timeFrame: 30 days
measure: Descriptive frequency of subjects experiencing toxicities.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
affiliation: Northwell Health
name: John Boockvar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.