Head and Neck Cancer
Conditions
Brief summary
The primary purpose of the study is to assess the safety of 111In-panitumumab as a molecular imaging agent in patients with Head and Neck Squamous Cell Carcinoma. The secondary objective is to compare sensitivity and specificity of identifying sentinel lymph nodes by systemic injection of 111In-panitumumab prior to Day of Surgery versus conventional local injection with an optical dye at the time of surgery.
Interventions
DRUG111I-n panitumumab
Imaging Agent
PROCEDURESingle photon emission computed tomography/computed tomography (SPECT/CT) scans
Day 1 to 5 (Day of Surgery inclusive)
Sponsors
American Cancer Society, Inc.
Stanford University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck. * Subjects diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Subjects with recurrent disease or a new primary will be allowed. * Planned standard of care elective neck dissection for a cN0 or cN1 disease. Clinical N1 disease will be defined as metastasis in a single, ipsilateral lymph node, 3 cm or less in greatest dimension by clinical exam, cross sectional imaging or metabolic imaging. * Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: * Hemoglobin ≥ 9 gm/dL * White blood cell count \> 3000/mm3 * Platelet count ≥ 100,000/mm3 * Serum creatinine ≤ 1.5 times upper reference range
Exclusion criteria
* Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment. * History of infusion reactions to monoclonal antibody therapies. * Pregnant or breastfeeding. * Magnesium or potassium lower than the normal institutional values. * Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. * Subjects with a history or evidence of interstitial pneumonitis or pulmonary fibrosis. * Severe renal disease or anuria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC. | 15 days | Number of CTCAE v5.0 Grade 2 or higher adverse events by Day 15 determined that are significant, definitely or probably related to 111In panitumumab. Safety data will be summarized by grade, severity, and type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye | 10 days after surgery | Sensitivity of systemic 111In panitumumab of identifying sentinel lymph nodes versus sensitivity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared |
| Compare specificity of systemic 111In panitumumab versus conventional local optical dye | 10 days after surgery | Specificity of systemic 111In panitumumab of identifying sentinel lymph nodes versus specificity of conventional local optical dye in identifying sentinel lymph nodes using histopathology will be compared |
Countries
United States
Outcome results
None listed