A Phase 3, Prospective, Open-Label, Multicenter Study of Lymphoseek
Sponsored by Navidea Biopharmaceuticals, the purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head & neck SCC. NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 is designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
The primary outcome is to measure a false negative rate in a 72-hour time frame. The secondary outcome is to measure the detection of cancer in the lymph nodes within 30 days.
Exclusions include: Patients that have a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx; patients that are pregnant or lactating; patients that have clinical or radiological evidence of metastatic cancer to the regional lymph nodes; patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck; patients who have had other nuclear imaging studies conducted within 15 days or consenting; patients actively receiving systemic cytotoxic chemotherapy, participating in another investigational drug study or participated within 30 days prior to consenting, or immunosuppressive or anti-monocyte or immunomodulatory therapy.
Inclusion criteria: Patients who have provided written informed consent with HIPAA authorization before participating in the study; have a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0; clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation; imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
Sentinel Lymph Node Localization and Biopsy for Conjunctival and Eyelid Melanoma
Sponsored by MD Anderson Cancer Center, the goal of this clinical research study is to find the sentinel lymph node (SLN) (s) and biopsy it (them) to see if the patient has small or low volume metastatic disease that would otherwise have been missed. Researchers hope to identify those patients who have microscopic lymph node disease before it becomes clinically obvious. With this technique, researchers could potentially identify occult metastatic disease, which would otherwise go unnoticed until it was too advanced. Patients in this study will have to see the ophthalmologist every three months and have the usual metastatic workup, which is routine for conjunctival/ eyelid melanoma.
The primary objectives are to identify the rate of SLN positivity in conjunctival/eyelid melanomas, and determine the false negative rate for SLN biopsy for the same. The secondary objective is to determine the complication rate for this technique, particularly with respect to local ocular and periocular side effects as well as the risk of facial nerve damage.
Exclusion Criteria: Pregnant or nursing females.
Inclusion Criteria: Participants must be 18 years of age or older; histologically documented malignant melanoma of the conjunctiva/eyelid greater than or equal to 1 millimeter in thickness, or those less than 1 mm thick that have evidence of ulceration, mitotic figures or are Clark IV; a CXR, liver enzymes, and a head and neck computed tomography (CT) or magnetic resonance imaging (MRI) negative for evidence of metastasis; must have a negative ultrasound of regional lymph nodes (ie,