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,
