Clinical trial NCT00911326: Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
Keywords: HNSCC
Lead sponsor: Navidea Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: False Negative Rate (FNR)
timeFrame: Surgery after injection of Lymphoseek
Secondary outcomes:
measure: Negative Predictive Value (NPV)
timeFrame: Surgery after injection of Lymphoseek
measure: Overall Accuracy
timeFrame: Surgery after injection of Lymphoseek
measure: Lymph Node Detection Rate
timeFrame: Surgery after injection of Lymphoseek
Other outcomes:
Locations:
city: Birminham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: San Diego
country: United States
facility: San Diego VA Hospital
state: California
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri-Ellis Fischel Cancer Center
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: Navidea Biopharmaceuticals
name: Bonnie C Abbruzzese, MS RD
role: STUDY_DIRECTOR
References:
citation: Agrawal A, Civantos FJ, Brumund KT, Chepeha DB, Hall NC, Carroll WR, Smith RB, Zitsch RP, Lee WT, Shnayder Y, Cognetti DM, Pitman KT, King DW, Christman LA, Lai SY. [(99m)Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial. Ann Surg Oncol. 2015 Oct;22(11):3708-15. doi: 10.1245/s10434-015-4382-x. Epub 2015 Feb 11.
citation: Marcinow AM, Hall N, Byrum E, Teknos TN, Old MO, Agrawal A. Use of a novel receptor-targeted (CD206) radiotracer, 99mTc-tilmanocept, and SPECT/CT for sentinel lymph node detection in oral cavity squamous cell carcinoma: initial institutional report in an ongoing phase 3 study. JAMA Otolaryngol Head Neck Surg. 2013 Sep;139(9):895-902. doi: 10.1001/jamaoto.2013.4239.