Panitumumab-IRDye800 Compared to Sentinel Node Biopsy and (Selective) Neck Dissection in Identifying Metastatic Lymph Nodes in Patients With Head and Neck Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 6/20/2018 |
| Start Date: | July 16, 2018 |
| End Date: | July 13, 2020 |
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 II 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.
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
I. 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:
I. 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 diagnosed with any T stage, any subsite within the head and neck that are
scheduled to undergo surgical resection, including a (modified) neck dissection
- Patients with recurrent disease or a new primary will be allowed
- Planned standard of care surgery with curative intent for squamous cell carcinoma
- Tumor is accessible for local injection of the sentinel node tracer (for example oral
cavity disease)
- Karnofsky performance status of at least 70% or Eastern Cooperative Oncology Group
(ECOG)/Zubrod level 1
- Hemoglobin >= 9 gm/dL
- White blood cell count > 3000/mm^3
- Platelet count >= 100,000/mm^3
- 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
- Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
amiodarone, sotalol) antiarrhythmic agents
- Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
- Hypersensitivity to dextran and/or modified form thereof
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Eben L. Rosenthal
Phone: 650-724-3866
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