Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

Phase II Study Evaluating Zr-Panitumumab for Assessment of Suspected Metastatic Lesions on 18F-FDG-PET/CT in Head and Neck Squamous Cell Carcinoma

The purpose of this study is to determine the diagnostic utility of 89Zr-panitumumab to identify metastatic lesion(s) in subjects with head and neck squamous cell carcinoma (HNSCC).

Study Overview

• Status: Not yet recruiting
• Conditions: Head-and-neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Panitumumab; Drug: 89Zr-panitumumab IV

Detailed Description

PRIMARY OBJECTIVE(S):

- Determine the sensitivity and specificity of 89Zr-panitumumab for the detection of suspected metastatic lesions

SECONDARY OBJECTIVE(S):

- Compare sensitivity and specificity of 18F-FDG-PET/CT and 89Zr-panitumumab-PET/CT for detection of suspected metastatic lesions

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Roan C Raymundo, BS; Phone Number: (650) 721-4071; Email: rcraymun@stanford.edu
• Study Contact Backup: Name: Grace Yi; Phone Number: 650-723-1423; Email: gracesyi@stanford.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94305
      • Stanford Cancer Institute
      • Sub-Investigator: Dimitrios Colevas, MD
      • Contact: Grace Yi; Phone Number: 650-723-1423; Email: gracesyi@stanford.edu
      • Contact: Roan C Raymundo, BS; Phone Number: 650-721-4071; Email: rcraymun@stanford.edu
      • Principal Investigator: Judy Nguyen, MD
      • Sub-Investigator: Yu-Jin Lee, MD, MS
      • Sub-Investigator: Andrei Iagaru, MD
      • Sub-Investigator: Carina Aparici, MD
      • Sub-Investigator: Guido Davidzon, MD
      • Sub-Investigator: Farshad Moradi, MD, PhD
      • Sub-Investigator: Benjamin L Franc, MD, MS, MBA
      • Sub-Investigator: Jagruti Shah, MBBS
      • Sub-Investigator: Saad Khan, MD
      • Sub-Investigator: Fred Baik, MD
      • Sub-Investigator: Chris Holsinger, MD
      • Sub-Investigator: Vasu Divi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 19 years.
• 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. Subjects with recurrent disease or a new primary will be allowed.
• Must have standard of care 18F-FDG-PET/CT scan ≤ 30 days of Day 0 with suspected metastatic lesions.

• Have acceptable hematological status, coagulation status, kidney function, and liver function including the following clinical results:

  • Hemoglobin ≥ 9gm/dL
  • White blood cell count > 3000/mm3
  • Platelet count ≥ 100,000/mm3
  • Serum creatinine ≤ 1.5 times upper reference range
  • PTT = 11.5 - 14.4 seconds
  • INR = 0.9 - 1.2

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 other 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
• Known hypersensitivity to deferoxamine or any of its components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: panitumumab 30 mg; Subjects will be given a 30mg of panitumumab	Drug: Panitumumab; Panitumumab 30mg will be given orally
Experimental: 89Zr-panitumumab IV; Subjects will be given 89Zr-panitumumab IV	Drug: 89Zr-panitumumab IV; Subjects will be given a bolus of 1.0 mCi (range 0.8 - 1.2 mCi) of 89Zr-panitumumab before undergoing further standard of care diagnostic evaluation of the lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of 89Zr-panitumumab	The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 89Zr-panitumumab using PET/CT imaging.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity 89Zr-panitumumab compared to standard of care 18F-FDG PET/CT imaging	The total number of head and neck squamous cell carcinoma-involved incidental lesions will be determined and correlated to the radiologically suspicious lesions identified by 18F-FDG using PET/CT imaging. The specificity and sensitivity of 89Zr-panitumumab will be compared to the specificity and sensitivity of 18F-FDG for identification of metastatic lesions.	Up to 1 year

Collaborators and Investigators

• Sponsor: Andrei Iagaru
• Investigators: Principal Investigator: Judy Nguyen, MD, Stanford Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: IRB-63234; ENT0095 (Other Identifier: Stanford OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No