Status:
SUSPENDED
Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer
Lead Sponsor:
Stanford University
Collaborating Sponsors:
American Cancer Society, Inc.
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 compar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04840472
Start Date
March 30 2021
End Date
March 1 2027
Last Update
December 24 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305