Trial Outcomes & Findings for Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck (NCT NCT00848042)

Last Updated: 2017-02-09

Results Overview

Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

up to 6 months

Results posted on

2017-02-09

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	5	5	1
Overall Study Day 1	5	5	1
Overall Study Day 2	5	5	1
Overall Study Day 3	5	5	1
Overall Study Day 8	5	5	1
Overall Study Day 15	4	5	1
Overall Study Month 1	4	5	1
Overall Study Month 2	1	5	1
Overall Study Month 3	1	4	1
Overall Study Month 4	1	4	1
Overall Study Month 5	1	3	1
Overall Study Month 6	1	3	1
Overall Study COMPLETED	1	3	1
Overall Study NOT COMPLETED	4	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	1	2	0
Overall Study Other Therapy	3	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AuroShell-3.5 n=5 Participants 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 n=5 Participants Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.	AuroShell-5.0 n=1 Participants Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=99 Participants	3 Participants n=107 Participants	1 Participants n=206 Participants	7 Participants n=157 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	2 Participants n=107 Participants	0 Participants n=206 Participants	4 Participants n=157 Participants
Gender Female	1 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	3 Participants n=157 Participants
Gender Male	4 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	8 Participants n=157 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=157 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=99 Participants	5 Participants n=107 Participants	1 Participants n=206 Participants	9 Participants n=157 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants	2 Participants n=157 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	4 Participants n=107 Participants	0 Participants n=206 Participants	9 Participants n=157 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=157 Participants
Region of Enrollment United States	5 participants n=99 Participants	5 participants n=107 Participants	1 participants n=206 Participants	11 participants n=157 Participants

PRIMARY outcome

Timeframe: up to 6 months

Population: per protocol

Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion

Outcome measures

Outcome measures
Measure	AuroShell-3.5 n=5 Participants 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 n=5 Participants Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.	AuroShell-5.0 n=1 Participants Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration	2 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: Data was not collected/analyzed

Outcome measures

Outcome data not reported

Adverse Events

AuroShell-3.5

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

AuroShell-4.5

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

AuroShell-5.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AuroShell-3.5 n=5 participants at risk 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 n=5 participants at risk Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.	AuroShell-5.0 n=1 participants at risk Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Cardiac disorders Cardiac Event	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm, Mouth	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Numbness	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.

Other adverse events

Additional Information

Robin Dickson

Nanospectra Biosciences, Inc.

Phone: 7138422720

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	AuroShell-3.5 n=5 participants at risk 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 n=5 participants at risk Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.	AuroShell-5.0 n=1 participants at risk Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
Blood and lymphatic system disorders Anemia, Unspecified	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Chills	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Immune system disorders Cough	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Blood and lymphatic system disorders Leukocytosis, Unspecified	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Skin and subcutaneous tissue disorders Erythema, NOS	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Respiratory, thoracic and mediastinal disorders Influenza	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Gastroesophageal Reflux	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Endocrine disorders Hyperkalemia	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Hypertension, Unspecified	40.0% 2/5 • Number of events 2 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Sinus Tachycardia	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Nervous system disorders Pain, Neoplasm Related	40.0% 2/5 • Number of events 2 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Pytalism	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Flushing	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Hypoxia	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/5 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Urinary Tract Infection	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
Musculoskeletal and connective tissue disorders Muscle Spasm	0.00% 0/5 • Up to 6 months post-study 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.	20.0% 1/5 • Number of events 1 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.
General disorders Generalized Pain	0.00% 0/5 • Up to 6 months post-study 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.	40.0% 2/5 • Number of events 2 • Up to 6 months post-study 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.	0.00% 0/1 • Up to 6 months post-study 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.