Ph 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 (retro-molar 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 pat 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,
within 6 weeks of study enrollment).
