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
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Head and Neck Squamous Cell Carcinoma (HNSCC)
Intervention: Drug: Lymphoseek

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lymphoseek Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.

Participant Flow:   Overall Study
    Lymphoseek  
STARTED     101  
COMPLETED     85  
NOT COMPLETED     16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of the 101 participants who enrolled in the trial, 85 were administered the study agent, Lymphoseek, and therefore this participant number is used for the baseline analysis.

Reporting Groups
  Description
Lymphoseek Enrolled patients who were administered any injection of Lymphoseek.

Baseline Measures
    Lymphoseek  
Number of Participants  
[units: participants]
  85  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     53  
>=65 years     32  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 12.8  
Gender  
[units: participants]
 
Female     21  
Male     64  
Region of Enrollment  
[units: participants]
 
United States     85  
Clinical tumor stage [1]
[units: participants]
 
T1     26  
T2     46  
T3     7  
T4     6  
Tumor location  
[units: participants]
 
Buccal mucosa     8  
Cutaneous     6  
Floor of the mouth     20  
Lower alveolar ridge     3  
Mucosal lip     1  
Oral tongue     43  
Retromolar gingiva     4  
[1]

From the American Joint Committee on Cancer, Manual for Staging of Cancer 6th Edition.

T1: tumor 2 cm or less in greatest dimension; T2: tumor more than 2 cm but not more than 4 cm (for lip and oral cavity SCC) or 5 cm (for cutaneous SCC) in greatest dimension; T3: tumor more than 4 cm (for lip and oral cavity SCC) or 5 cm (for cutaneous SCC) in greatest dimension; T4: tumor invades adjacent structures (for lip and oral cavity SCC) or deep extradermal structures (for cutaneous SCC).




  Outcome Measures
  Show All Outcome Measures

1.  Primary:   False Negative Rate (FNR)   [ Time Frame: Surgery after injection of Lymphoseek ]

2.  Secondary:   Negative Predictive Value (NPV)   [ Time Frame: Surgery after injection of Lymphoseek ]

3.  Secondary:   Overall Accuracy   [ Time Frame: Surgery after injection of Lymphoseek ]

4.  Secondary:   Lymph Node Detection Rate   [ Time Frame: Surgery after injection of Lymphoseek ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was prospectively structured to include an interim analysis at 33.3% enrollment. The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and lack of safety concern.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Frederick O. Cope, Chief Scientific Officer
Organization: Navidea Biopharmaceuticals
phone: 614-793-7500 ext 140
e-mail: fcope@navidea.com


No publications provided by Navidea Biopharmaceuticals

Publications automatically indexed to this study:

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