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
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
This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck cancer that has spread to the lymph nodes in patients with head and neck cancer. Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy than the current methods.
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.
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
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: