Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

Phase 3

Terminated

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Registration Number: NCT00911326

Lead Sponsor: Navidea Biopharmaceuticals

Brief Summary: 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 squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:

The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
The patient has 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.
The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
Patients with prior malignancy are allowed provided the patient meets the following criteria:

Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; AND No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence.
The patient is at least 18 years of age at the time of consent.
The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.
If the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of Lymphoseek, OR has documentation of surgical sterilization, OR has documented evidence of postmenopausal status for at least 1 year.

Exclusion Criteria

Patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study:

The patient has 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.
The patient is pregnant or lactating.
The patient has 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.
The patient is actively receiving systemic cytotoxic chemotherapy.
Patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
False Negative Rate (FNR)	Surgery after injection of Lymphoseek	The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.

Secondary Outcome Measures

Name	Time	Method
Negative Predictive Value (NPV)	Surgery after injection of Lymphoseek	The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.
Overall Accuracy	Surgery after injection of Lymphoseek	The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.
Lymph Node Detection Rate	Surgery after injection of Lymphoseek	The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.

Trial Locations

Locations (13): University of Alabama, Birmingham
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Birminham, Alabama, United States
University of Miami, Sylvester Comprehensive Cancer Center
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Miami, Florida, United States
San Diego VA Hospital
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San Diego, California, United States
University of Nebraska
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Omaha, Nebraska, United States
Duke University Medical Center
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Durham, North Carolina, United States
The Ohio State University Comprehensive Cancer Center
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Columbus, Ohio, United States
University of Missouri-Ellis Fischel Cancer Center
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Columbia, Missouri, United States
Moores UCSD Cancer Center
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La Jolla, California, United States
University of Michigan Medical Center
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Ann Arbor, Michigan, United States
University of Mississippi
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Jackson, Mississippi, United States
MD Anderson
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Houston, Texas, United States
University of Kansas Medical Center
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Kansas City, Kansas, United States
Thomas Jefferson University
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Philadelphia, Pennsylvania, United States