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Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanospectra Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00848042
First received: February 19, 2009
Last updated: September 20, 2016
Last verified: September 2016
Results First Received: June 7, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head and Neck Cancer
Intervention: Device: AuroLase Therapy

  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
Subjects screened and enrolled at four sites in the United States.

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
AuroShell-3.5 Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
AuroShell-4.5 Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
AuroShell-5.0 Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.

Participant Flow:   Overall Study
    AuroShell-3.5   AuroShell-4.5   AuroShell-5.0
STARTED   5   5   1 
Day 1   5   5   1 
Day 2   5   5   1 
Day 3   5   5   1 
Day 8   5   5   1 
Day 15   4   5   1 
Month 1   4   5   1 
Month 2   1   5   1 
Month 3   1   4   1 
Month 4   1   4   1 
Month 5   1   3   1 
Month 6   1   3   1 
COMPLETED   1   3   1 
NOT COMPLETED   4   2   0 
Death                1                2                0 
Other Therapy                3                0                0 



  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.
No text entered.

Reporting Groups
  Description
AuroShell-3.5 Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
AuroShell-4.5 Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
AuroShell-5.0 Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Total Total of all reporting groups

Baseline Measures
   AuroShell-3.5   AuroShell-4.5   AuroShell-5.0   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   1   11 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   3   3   1   7 
>=65 years   2   2   0   4 
Gender 
[Units: Participants]
       
Female   1   1   1   3 
Male   4   4   0   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   2   0   0   2 
Not Hispanic or Latino   3   5   1   9 
Unknown or Not Reported   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   0   0   0   0 
Asian   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0 
Black or African American   0   1   1   2 
White   5   4   0   9 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   5   5   1   11 


  Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration   [ Time Frame: up to 6 months ]

2.  Secondary:   Response in Targeted Tumors.   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Robin Dickson
Organization: Nanospectra Biosciences, Inc.
phone: 7138422720 ext 216
e-mail: rdickson@nanospectra.com



Responsible Party: Nanospectra Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00848042     History of Changes
Other Study ID Numbers: NBI-07-001
Study First Received: February 19, 2009
Results First Received: June 7, 2016
Last Updated: September 20, 2016
Health Authority: United States: Food and Drug Administration