Back to results

Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Suspended

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

111I-n panitumumab

Single photon emission computed tomography/computed tomography (SPECT/CT) scans

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

111-In panitumumab

Arm Description

The study drug (111In panitumumab) 5 mCi, allowable range 4.5 to 5.5 will be administered on Day 0, and subjects will undergo one 111In panitumumab SPECT/CT imaging anytime between Day 1 and Day of Surgery. Subjects will undergo surgical resection after infusion of 111In panitumumab.

Outcomes

Primary Outcome Measures

Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.

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 Outcome Measures

Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye

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

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

Full Information

NCT ID

NCT04840472

First Posted

April 7, 2021

Last Updated

March 17, 2023

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT04840472

Brief Title

Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Official Title

Pilot Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Suspended

Why Stopped

Logistics

Study Start Date

March 30, 2021 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

111-In panitumumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

111I-n panitumumab

Intervention Description

Imaging Agent

Intervention Type

Procedure

Intervention Name(s)

Single photon emission computed tomography/computed tomography (SPECT/CT) scans

Intervention Description

Day 1 to 5 (Day of Surgery inclusive)

Primary Outcome Measure Information:

Title

Assess the safety of 111In panitumumab as a molecular imaging agent in patients with HNSCC.

Description

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Compare sensitivity of systemic 111In panitumumab versus conventional local optical dye

Description

Time Frame

10 days after surgery

Title

Compare specificity of systemic 111In panitumumab versus conventional local optical dye

Description

Time Frame

10 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fred Baik, MD

Organizational Affiliation

Stanford Universiy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study Evaluating 111In-Panitumumab for Nodal Staging in Head and Neck Cancer

We'll reach out to this number within 24 hrs