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

This study has been terminated.
(The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00911326
First received: May 28, 2009
Last updated: August 6, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma (HNSCC)
Drug: Lymphoseek
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Navidea Biopharmaceuticals:

Primary Outcome Measures:
  • False Negative Rate (FNR) [ Time Frame: Surgery after injection of Lymphoseek ] [ Designated as safety issue: No ]
    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:
  • Negative Predictive Value (NPV) [ Time Frame: Surgery after injection of Lymphoseek ] [ Designated as safety issue: No ]
    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 [ Time Frame: Surgery after injection of Lymphoseek ] [ Designated as safety issue: No ]
    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 [ Time Frame: Surgery after injection of Lymphoseek ] [ Designated as safety issue: No ]
    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.


Enrollment: 101
Study Start Date: May 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lymphoseek
    Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m
    Other Name: Tc-99m Tilmanocept (Lymphoseek)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
  2. 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.
  3. 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.
  4. Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
  5. The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
  6. 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.

  7. The patient is at least 18 years of age at the time of consent.
  8. The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.
  9. 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:

  1. 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.
  2. The patient is pregnant or lactating.
  3. The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
  4. 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.
  5. Patients who have had other nuclear imaging studies conducted within 15 days or consenting.
  6. The patient is actively receiving systemic cytotoxic chemotherapy.
  7. Patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
  8. Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911326

Locations
United States, Alabama
University of Alabama, Birmingham
Birminham, Alabama, United States, 35294
United States, California
Moores UCSD Cancer Center
La Jolla, California, United States, 92093
San Diego VA Hospital
San Diego, California, United States, 92161
United States, Florida
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, Mississippi
University of Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
University of Missouri-Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
Study Director: Bonnie C Abbruzzese, MS RD Navidea Biopharmaceuticals
  More Information

No publications provided by Navidea Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00911326     History of Changes
Other Study ID Numbers: NEO3-06
Study First Received: May 28, 2009
Results First Received: July 8, 2014
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Navidea Biopharmaceuticals:
HNSCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on August 28, 2014