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Panitumumab IRDye800 Optical Imaging Study

Primary Purpose

Head and Neck Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Panitumumab IRDye 800

da Vinci Firefly

IMAGE1 + ICG Hopkins telescope and/or VITOM

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring Panitumumab, Optical Imaging

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
Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
Planned standard of care surgery with curative intent for squamous cell carcinoma
Age ≥ 19 years
Have life expectancy of more than 12 weeks
Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
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

Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800
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 monoclonal antibody therapies
Pregnant or breastfeeding
Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
Magnesium or potassium lower than the normal institutional values
Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
TSH > 13 micro International Units/mL

Sites / Locations

University of Alabama at Birmingham Cancer Center
Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Panitumumab IRDye 800

Arm Description

Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Outcomes

Primary Outcome Measures

Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events

Safety profile of panitumumab conjugated to IRDye800CW (panitumumab IRDye800) will be measured by assessing number of Grade 2 or higher adverse events which have been determined to be clinically significant and definitely, probably or possibly related.

Secondary Outcome Measures

Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio

Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue.

Optimal timing of the surgical procedure to maximize tumor to background ratio

Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts

Full Information

NCT ID

NCT02415881

First Posted

March 26, 2015

Last Updated

September 22, 2021

Sponsor

Eben Rosenthal

1. Study Identification

Unique Protocol Identification Number

NCT02415881

Brief Title

Panitumumab IRDye800 Optical Imaging Study

Official Title

Phase I, Open-label Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Head and Neck Cancer During Surgical Procedures

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

November 23, 2019 (Actual)

Study Completion Date

September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eben Rosenthal

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Phase I trial to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent.

Detailed Description

This is a Phase I trial that is designed to evaluate the safety of escalating dose levels of conjugated panitumumab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Safety data from this trial will be studied to assist in the selection of dose levels of panitumumab-IRDye800 for future research. It is hoped that this study will also help in finding better methods for identifying cancer intraoperatively for a more complete surgical resection.

6. Conditions and Keywords

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

Head and Neck Cancer

Keywords

Panitumumab, Optical Imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Panitumumab IRDye 800

Arm Type

Experimental

Arm Description

Patients will receive Panitumumab IRDye800 prior to their scheduled surgery.

Intervention Type

Drug

Intervention Name(s)

Panitumumab IRDye 800

Other Intervention Name(s)

Optical Imaging prior to surgery

Intervention Description

Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery

Intervention Type

Device

Intervention Name(s)

da Vinci Firefly

Intervention Description

Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)

Intervention Type

Device

Intervention Name(s)

IMAGE1 + ICG Hopkins telescope and/or VITOM

Intervention Description

IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.

Primary Outcome Measure Information:

Title

Safety profile of panitumumab conjugated panitumumab IRDye800 will be measured by assessing number of Grade 2 or higher adverse events

Description

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio

Description

Efficacy of panitumumab IRDye800 will be measured by tumor to background ratio. Fluorescence intensity of tumor tissue compared to that of normal surrounding tissue.

Time Frame

7 days

Title

Optimal timing of the surgical procedure to maximize tumor to background ratio

Description

Fluorescence intensity of tissue obtained from patients undergoing surgery at different time points in various cohorts

Time Frame

7 days

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 Patients diagnosed with any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed. Planned standard of care surgery with curative intent for squamous cell carcinoma Age ≥ 19 years Have life expectancy of more than 12 weeks Karnofsky performance status of at least 70% or ECOG/Zubrod level 1 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 Received an investigational drug within 30 days prior to first dose of panitumumab IRDye800 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 monoclonal antibody therapies Pregnant or breastfeeding Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) Magnesium or potassium lower than the normal institutional values Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis TSH > 13 micro International Units/mL

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eben L Rosenthal, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Stanford University, School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33168818

Citation

Lu G, Nishio N, van den Berg NS, Martin BA, Fakurnejad S, van Keulen S, Colevas AD, Thurber GM, Rosenthal EL. Co-administered antibody improves penetration of antibody-dye conjugate into human cancers with implications for antibody-drug conjugates. Nat Commun. 2020 Nov 9;11(1):5667. doi: 10.1038/s41467-020-19498-y.

Results Reference

derived

PubMed Identifier

33078373

Citation

Kapoor S, Lu G, van den Berg NS, Krishnan G, Pei J, Zhou Q, Martin BA, Baik FM, Rosenthal EL, Nishio N. Effect of Formalin Fixation for Near-Infrared Fluorescence Imaging with an Antibody-Dye Conjugate in Head and Neck Cancer Patients. Mol Imaging Biol. 2021 Apr;23(2):270-276. doi: 10.1007/s11307-020-01553-1. Epub 2020 Oct 19.

Results Reference

derived

PubMed Identifier

31421471

Citation

Fakurnejad S, van Keulen S, Nishio N, Engelen M, van den Berg NS, Lu G, Birkeland A, Baik F, Colevas AD, Rosenthal EL, Martin BA. Fluorescence molecular imaging for identification of high-grade dysplasia in patients with head and neck cancer. Oral Oncol. 2019 Oct;97:50-55. doi: 10.1016/j.oraloncology.2019.08.008. Epub 2019 Aug 12.

Results Reference

derived

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Panitumumab IRDye800 Optical Imaging Study

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