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Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

Primary Purpose

Head and Neck Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cetuximab-IRDye800

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer focused on measuring HNSCC, 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 ≥ 9gm/dL
- Platelet count ≥ 100,000/mm3
- Magnesium, potassium and calcium greater than or equal than the lower limit of normal range per institution normal lab values
- TSH <10 micro International Units/mL

Exclusion Criteria:

Received an investigational drug within 30 days prior to first dose of cetuximab-IRDye800
Had within 6 months prior to enrollment: MI, CVA, uncontrolled CHF, significant liver disease, unstable angina
Inadequately controlled hypertension with or without current antihypertensive medications
History of infusion reactions to cetuximab or other monoclonal antibody therapies.
Women who are pregnant or breast feeding
Patients who have a grade 2 or greater reaction with the test/loading cetuximab dose.
Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females).
Lab values that in the opinion of the primary surgeon would prevent surgical resection.
Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
Patients with TSH>11

Sites / Locations

Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab-IRDye800 Participants

Arm Description

Participants who received the study drug cetuximab-IRDye800, following a loading dose of unlabeled cetuximab

Outcomes

Primary Outcome Measures

Number of subjects in a cohort experiencing a DLT (gr 2 or greater AE considered at least possibly related to study drug & clinically significant by the PI) after receiving cetuximab conjugated to the optical dye IRDye800CW(cetuximab-IRDye800)

Secondary Outcome Measures

Number of subjects with identifiable cancer as compared to surrounding normal tissue by correlating fluorescence with histological evidence of tumor post receipt of cetuximab conjugated to the optical dye, IRDye800CW (cetuximab-IRDye800)

Full Information

NCT ID

NCT01987375

First Posted

October 8, 2013

Last Updated

June 21, 2019

Sponsor

Eben Rosenthal

1. Study Identification

Unique Protocol Identification Number

NCT01987375

Brief Title

Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Why Stopped

logistics

Study Start Date

November 2015 (undefined)

Primary Completion Date

April 19, 2017 (Actual)

Study Completion Date

April 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eben Rosenthal

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is an open label, single institution, Phase 1 dose-escalation study to determine the safety profile of cetuximab-IRDye800 used in subjects with head and neck squamous cell carcinoma (HNSCC) that undergo surgery with curative intent. Participants will be given a dose of an approved head and neck cancer drug (Cetuximab) along with an investigational study drug called Cetuximab-IRDye800. Cetuximab-IRDye800 is a drug that is given prior to surgery that attaches to cancer cells and appears to make them visible to the doctor when he uses a special camera during the operation. The investigators are evaluating whether or not the use of the study drug along with the special camera will better identify the cancer while patients are in the operating room.

Detailed Description

This study will be a conventional 3+3 phase I study evaluating three escalating dose levels of intravenous infusion of cetuximab-IRDye800 for patients who tolerate a 100 mg test/loading dose of unlabeled cetuximab as part of the screening process. Two cohorts will be added that do not include a 100 mg unlabeled test/loading dose of cetuximab, but will include a 10 mg test dose prior to enrollment. One cohort of 6 patients will be added that includes a 100 mg unlabeled test/loading dose of cetuximab and a fixed 50 mg dose of cetuximab-IRDye800.

6. Conditions and Keywords

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

Head and Neck Cancer

Keywords

HNSCC, 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

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cetuximab-IRDye800 Participants

Arm Type

Experimental

Arm Description

Participants who received the study drug cetuximab-IRDye800, following a loading dose of unlabeled cetuximab

Intervention Type

Drug

Intervention Name(s)

Cetuximab-IRDye800

Intervention Description

a single dose of the study drug following a single loading dose of unlabeled cetuximab

Primary Outcome Measure Information:

Title

Time Frame

30 days post intervention

Secondary Outcome Measure Information:

Title

Time Frame

One year post intervention

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 ≥ 9gm/dL Platelet count ≥ 100,000/mm3 Magnesium, potassium and calcium greater than or equal than the lower limit of normal range per institution normal lab values TSH <10 micro International Units/mL Exclusion Criteria: Received an investigational drug within 30 days prior to first dose of cetuximab-IRDye800 Had within 6 months prior to enrollment: MI, CVA, uncontrolled CHF, significant liver disease, unstable angina Inadequately controlled hypertension with or without current antihypertensive medications History of infusion reactions to cetuximab or other monoclonal antibody therapies. Women who are pregnant or breast feeding Patients who have a grade 2 or greater reaction with the test/loading cetuximab dose. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females). Lab values that in the opinion of the primary surgeon would prevent surgical resection. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Patients with TSH>11

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eben Rosenthal, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University, School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

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Cetuximab IRDye800 Study as an Optical Imaging Agent to Detect Cancer During Surgical Procedures

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