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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00848042
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : July 18, 2016
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Nanospectra Biosciences, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head and Neck Cancer
Intervention Device: AuroLase Therapy
Enrollment 11
Recruitment Details Subjects screened and enrolled at four sites in the United States.
Pre-assignment Details  
Arm/Group Title AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Hide Arm/Group Description Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Period Title: Overall Study
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
Reason Not Completed
Death             1             2             0
Other Therapy             3             0             0
Arm/Group Title AuroShell-3.5 AuroShell-4.5 AuroShell-5.0 Total
Hide Arm/Group Description Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts. Total of all reporting groups
Overall Number of Baseline Participants 5 5 1 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 1 participants 11 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  60.0%
3
  60.0%
1
 100.0%
7
  63.6%
>=65 years
2
  40.0%
2
  40.0%
0
   0.0%
4
  36.4%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 1 participants 11 participants
Female
1
  20.0%
1
  20.0%
1
 100.0%
3
  27.3%
Male
4
  80.0%
4
  80.0%
0
   0.0%
8
  72.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 1 participants 11 participants
Hispanic or Latino
2
  40.0%
0
   0.0%
0
   0.0%
2
  18.2%
Not Hispanic or Latino
3
  60.0%
5
 100.0%
1
 100.0%
9
  81.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 1 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  20.0%
1
 100.0%
2
  18.2%
White
5
 100.0%
4
  80.0%
0
   0.0%
9
  81.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 1 participants 11 participants
5 5 1 11
1.Primary Outcome
Title Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration
Hide Description Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion
Time Frame up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol
Arm/Group Title AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Hide Arm/Group Description:
Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Overall Number of Participants Analyzed 5 5 1
Measure Type: Number
Unit of Measure: participants
2 2 0
2.Secondary Outcome
Title Response in Targeted Tumors.
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected/analyzed
Arm/Group Title AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Hide Arm/Group Description:
Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 6 months post-study
Adverse Event Reporting Description

If a subject experienced more than one event, the subject is only counted once for the most severe event. If a subject experience more than one event in an system class, the subject is only counted once.

All adverse events are being reported regardless of relation to study treatment.
 
Arm/Group Title AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Hide Arm/Group Description Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts. Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
All-Cause Mortality
AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      2/5 (40.00%)      0/1 (0.00%)    
Cardiac disorders       
Cardiac Event † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
General disorders       
Numbness † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm, Mouth † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9-CM
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AuroShell-3.5 AuroShell-4.5 AuroShell-5.0
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      4/5 (80.00%)      0/1 (0.00%)    
Blood and lymphatic system disorders       
Anemia, Unspecified † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Leukocytosis, Unspecified † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Endocrine disorders       
Hyperkalemia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
General disorders       
Chills † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Gastroesophageal Reflux † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Hypertension, Unspecified † 1  2/5 (40.00%)  2 1/5 (20.00%)  1 0/1 (0.00%)  0
Sinus Tachycardia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Pytalism † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Flushing † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Hypoxia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Urinary Tract Infection † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Generalized Pain † 1  0/5 (0.00%)  0 2/5 (40.00%)  2 0/1 (0.00%)  0
Immune system disorders       
Cough † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle Spasm † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
Nervous system disorders       
Pain, Neoplasm Related † 1  2/5 (40.00%)  2 0/5 (0.00%)  0 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Influenza † 1  1/5 (20.00%)  1 0/5 (0.00%)  0 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema, NOS † 1  0/5 (0.00%)  0 1/5 (20.00%)  1 0/1 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, ICD-9-CM
[Not Specified]
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin Dickson
Organization: Nanospectra Biosciences, Inc.
Phone: 7138422720 ext 216
EMail: rdickson@nanospectra.com
Layout table for additonal information
Responsible Party: Nanospectra Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00848042    
Other Study ID Numbers: NBI-07-001
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: June 7, 2016
Results First Posted: July 18, 2016
Last Update Posted: February 9, 2017