- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405142
Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head&Neck Cancer
A Phase II Study Evaluating Panitumumab-IRDye800 vs. Sentinel Node Biopsy and (Selective) Neck Dissection for Metastatic Lymph Node Identification in Patients With Head and Neck Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detecting progression of squamous cell carcinoma of the head and neck (SCCHN) is clinically challenging, with the transition from Stage 2 (no metastasis) to Stage 3 or 4 (minimally to significantly metastatic) representing a significant and adverse clinical milestone. SCCHN often spreads by movement of metastatic cells through the lymphatic system. Often, these cells are retained in various lymph nodes (LNs), of which there are over 150 on each side of the head and neck. Logically, the objective of neck dissection would be the removal of obvious cancer and any LNs containing metastatic cells. However, with visual or even radiologic identification of cancerous LNs was challenging at best, definitive assessment of the spread of the cancer must be made on excised tissue in the clinical laboratory by pathologic assessment. Historically, a marker of successful neck dissection for SCCHN was excision of sufficient LNs such that the extent of tumor-positive LNs would be demonstrated by pathology. Accordingly, many LNs are excised that turn out to be negative for invasive tumor cells. Unfortunately, neck dissection is often accompanied by significant morbidity, such as shoulder dysfunction or injury to the cranial nerve XI or other nerves causing persistent pain, as well as anatomic deformities such as scapular flaring, droop, and protraction. In recent years, a more limited dissection procedure known as sentinel lymph node biopsy (SNB) has become common, with the advantage of being less invasive, and targeted to only the LNs believed to the primary drainage of the tumor. Sentinel lymph nodes are those believed to be most likely to collect tumor cells migrating from the tumor lesion. The goal of SNB is a more precise identification of those LNs that have or are likely to have metastatic cells, with fewer LNs collected and less morbidity. Pathological assessment of the SNBs enhances clinical decision making for further treatment. While SNB represents an overall improvement, there remains opportunity for better detection of metastatic LNs with less morbidity.
In this study, the specific medical imaging scan is known as lymphoscintigraphy and is conducted as single-photon emission computerized tomography (SPECT) scan with computed tomography (CT), collectively "SPECT/CT" using the radiolabel Lymphoseek (99mTc Tilmanocept). Lymphoseek is administered as 4 injections to LNs that are in the immediate vicinity of the known tumor lesion.
The surgical procedure is known as lymphadenectomy, meaning excision of lymph nodes. In this study, the excised lymph nodes are those suspected as being positive for malignancy and the basis of they as SPECT/CT lymphoscintigraphy.
The panitumumab-IRDye800 agent is intended to bind to cancer cells, and enable detection of those cells on the basis of IRDye800 fluorescence. The panitumumab-IRDye800 is administered as an intravenous infusion over 15 minutes. The label is specific to a marker on tumor cells, and migrates through the body and adheres to cancer cells, permitting their identification visually or by fluorescence detectors. Immediately before and after excision, the area around the lymph nodes are evaluated for the fluorescent signal of the panitumumab-IRDye800. Additional areas of panitumumab-IRDye800 may be excised. The potential advantage of panitumumab-IRDye800 labeling is that signaling is assessed intraoperatively, and this may enable more accurate and more precise determination of the tumor in LNs and other tissue.
In this study, participants with SCCHN that is T1 or T2 stage and node-negative (ie, cN0) (Cohort 1) will undergo labeling procedures with Lymphoseek (99mTc Tilmanocept), a regular medical care radiolabel and also investigational panitumumab-IRDye800. Participants whose SCCHN is node positive and any T stage (Cohort 2) can participate and undergo labeling with investigational panitumumab-IRDye800 alone.
PRIMARY OBJECTIVES:
To determine if near-infrared fluorescence imaging of panitumumab-IRDye800 can identify metastatic disease in regional neck lymph nodes of patients with head and neck squamous cell carcinoma (HNSCC).
SECONDARY OBJECTIVES:
Determine if panitumumab-IRDye800 can identify sentinel nodes with the same accuracy as technetium Tc 99m-labeled tilmanocept (Lymphoseek).
OUTLINE:
Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 intravenously (IV) over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled tilmanocept via injection and undergo lymphoscintigraphy and single photon emission computed tomography/computed tomography (SPECT/CT).
After completion of study, patients are followed up for 30 days.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford University, School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
- Biopsy-confirmed diagnosis of squamous cell carcinoma of the head and neck
- Patients with recurrent disease or a new primary will be allowed
Planned standard of care surgery with curative intent for squamous cell carcinoma
- Cohort 1: T1-T2 stage tumor diagnosis, any subsite within the head and neck that is amenable to local sentinel node tracer injection, and scheduled to undergo surgical resection of the tumor, including a sentinel node biopsy
- Cohort 2 (neck dissection only): Diagnosis with any T-stage, any subsite within the head and neck that are scheduled to undergo surgical resection, including a (modified) neck dissection
- Age ≥ 19 years
- 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
- Magnesium or potassium lower than the normal institutional values
- Receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
- History or evidence of interstitial pneumonitis or pulmonary fibrosis
- Hypersensitivity to dextran and/or modified forms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: T1 or T2 stage and node-negative
T1 or T2 stage primary tumor and node-negative (ie, cN0)
|
Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy).
Panitumumab dose is < 1/12 of the therapeutic dose.
Other Names:
Local, peri-tomoral injection with 2 mCi Lymphoseek (99mTc Tilmanocept) (as 4 x 0.1 mL injections of Lymphoseek solution
Other Names:
|
Experimental: Any T stage and node-positive
Any T stage tumor and node-positive (ie, cN+)
|
Intravenous (IV) panitumumab-IRDye800 (50 mg) 1 to 5 days prior to surgery (lymphadenectomy).
Panitumumab dose is < 1/12 of the therapeutic dose.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection of Malignancy in Excised Lymph Nodes by Pathology or Labeling With Lymphoseek and/or Panitumumab-IRDye800
Time Frame: Up to 30 days
|
After administration of panitumumab-IRDye800 alone or with Lymphoseek, lymph nodes potentially containing malignant tumor cells were surgically removed, and the lymph node tissue was evaluated for panitumumab-IRDye800 fluorescence intensity.
For each subject, the 5 lymph nodes with the strongest fluorescence signal were tabulated against the Lymphoseek and histopathologic findings for those specific lymph nodes.
For each of the 3 modalities, a positive finding is considered indicative of malignancy.
The outcome is reported as the number of positive findings by modality for each cohort.
The outcome is a number without dispersion.
|
Up to 30 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Fred M Baik, Stanford Cancer Institute Palo Alto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Head and Neck Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Protective Agents
- Antineoplastic Agents, Immunological
- Anticoagulants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Plasma Substitutes
- Blood Substitutes
- Iron Chelating Agents
- Calcium Chelating Agents
- Nitric Oxide Donors
- Panitumumab
- Edetic Acid
- Pentetic Acid
- Dextrans
- Diethylenetriamine
Other Study ID Numbers
- IRB-43013
- P30CA124435 (U.S. NIH Grant/Contract)
- NCI-2017-02425 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- ENT0065 (Other Identifier: OnCore Number)
- R01CA190306 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer
-
Robert FerrisAmgenCompletedHead and Neck Cancer | Cancer of Head and Neck | Head Cancer | Neck Cancer | Neoplasms, Head and Neck | Cancer of the Head and Neck | Cancer of Neck | Upper Aerodigestive Tract Neoplasms | Neck Neoplasms | Cancer of the Head | Cancer of the Neck | UADT Neoplasms | Cancer of Head | Head Neoplasms | Head, Neck Neoplasms | Neoplasms, Head and other conditionsUnited States
-
Assiut UniversityRecruitingHead and Neck Cancer | Head and Neck Neoplasms | Cancer of Head and Neck | Neoplasms, Head and Neck | Cancer of the Head and NeckEgypt
-
Mayo ClinicRecruitingCancer Head Neck | Cancer Neck | Cancer, HeadUnited States
-
IRCCS Policlinico S. MatteoNestlé Health Science Spain; Akern SrlCompletedHead-neck CancerItaly
-
University of California, San FranciscoCompleted
-
Chinook Therapeutics, Inc. (formerly Aduro)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedHead And Neck CancerUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Head and Neck Cancer | Metastatic Head and Neck CancerUnited States
-
Radboud University Medical CenterUnknown
-
Centre Oscar LambretUnknownEpidermoid Head and Neck CancerFrance
Clinical Trials on Panitumumab-IRDye800
-
University of Alabama at BirminghamRecruiting
-
Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)RecruitingHead and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Squamous Cell CarcinomaUnited States
-
Stanford UniversityNot yet recruitingBrain TumorUnited States
-
Eben RosenthalRecruitingStage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Lung Carcinoma | Metastatic Malignant Neoplasm in the LungUnited States
-
Andrei IagaruNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedSquamous Cell Carcinoma of the Head and Neck | Carcinoma of the Head and NeckUnited States
-
Eben RosenthalNational Cancer Institute (NCI)RecruitingPancreatic AdenocarcinomaUnited States
-
Eben RosenthalNational Institutes of Health (NIH)Active, not recruitingMalignant Glioma | Malignant Brain NeoplasmUnited States
-
University of MichiganCompleted
-
Beijing Institute of Heart, Lung and Blood Vessel...Beijing Tiantan Hospital; Southwest Hospital, China; Nanfang Hospital of Southern... and other collaboratorsUnknown
-
Spanish Cooperative Group for the Treatment of...AmgenCompleted