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Head and Neck CancerPhase 1NCT01987375

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

A Phase 1 study testing Cetuximab-IRDye800 in people with Head and Neck Cancer, run by Eben Rosenthal at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab-IRDye800
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Nov 2015to 19 Apr 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cetuximab-IRDye800
Keywords
HNSCC, Imaging
Medical subject headings
Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cetuximab-IRDye800Drug

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

Study groups in NCT01987375
Study groupRoleWhat they receive
Cetuximab-IRDye800 ParticipantsExperimentalParticipants who received the study drug cetuximab-IRDye800, following a loading dose of unlabeled cetuximab
Receives: Drug: Cetuximab-IRDye800

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 30 days post intervention

Secondary outcomes (1)

  1. 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)

    Measured: One year post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study startNov 2015
  3. Primary completion19 Apr 2017
  4. Study completion19 Apr 2017

Why it stopped: logistics

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987375
Sponsor's protocol ID
IRB-35068
Other IDs
ENT0049
Status last verified
Jun 2019
First submitted
8 Oct 2013
Last updated
24 Jun 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cetuximab-IRDye800 in people with Head and Neck Cancer, run by Eben Rosenthal at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: logistics). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 30 days post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.

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