- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00848042
Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck
December 19, 2016 updated by: Nanospectra Biosciences, Inc.
A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck
This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the treatment of patients with refractory and/or recurrent tumors of the head and neck.
Three (3) treatment groups of five (5) patients each will be enrolled and observed for six (6) months following treatment.
Each group will receive a single dose of AuroShell(TM) particles followed by one or more interstitial illuminations with an 808nm laser.
Particle dose and laser power may be increased in each dosing group.
Study Overview
Study Type
Interventional
Enrollment (Actual)
11
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arizona
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Goodyear, Arizona, United States, 85338
- Cancer Treatment Centers of American Western Regional Medical Center
-
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 128 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have documented histological or cytological evidence of tumor(s) of the head and neck
- Patients must have one or more refractory and/or recurrent tumors of the head and neck which have at least one dimension with longest diameter 15 mm using conventional techniques or 10 mm with spiral CT scan.
- Target lesions should be accessible to examination (examination by fiber optic nasopharyngoscopy or laryngoscopy is permitted) and to biopsy.
- Each index lesion should be large enough to provide at least 6 mg of tumor tissue by biopsy (such as an 18 gauge Tru-Cut needle biopsy 1cm in length or similar technique) for assessment by neutron activation analysis.
- Tumors must be measurable according to RECIST criteria
- Patients must be ≥ 18 years of age
- Patients must have ECOG Performance Score of 0, 1 or 2 (see Appendix 3)
- Patients or their legal representative must be able to read, understand and sign an informed consent
- Adequate renal function as evidenced by serum creatinine ≤ 2.0 mg/dL
- Adequate hepatic function as evidenced by: Serum total bilirubin ≤ 2.0 mg/dL, Alkaline phosphatase ≤ 2X the ULN for the reference lab, SGOT/SGPT ≤ 2X the ULN for the reference lab
- Women of childbearing potential must agree to use an effective form of contraception during the study and for 90 days following treatment (an effective form of contraception is an oral contraceptive or a double barrier method). Women who are NOT of childbearing potential are those who have undergone a bilateral oophorectomy or who have undergone menopause, defined as an absence of a menstrual cycle for 12 consecutive months.
- Negative pregnancy test for women of childbearing potential.
Exclusion Criteria:
- Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold)
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Patients who are pregnant and/or lactating
- Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing
- Patients who have undergone splenectomy
- Patient who has had a course of radiotherapy in the treatment area within the past 30 days.
- Patient who has had a course of chemotherapy or other anti-neoplastic therapy in the past 30 days.
- Patient who has had surgery within 2 cm of the treatment area within the past two weeks.
- Life expectancy of less than 3 months.
- Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
Device: AuroLase Therapy
|
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions
|
Active Comparator: AuroShell-4.5
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 4.5 watts.
Device: AuroLase Therapy
|
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions
|
Active Comparator: AuroShell-5.0
Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 5.0 watts.
Device: AuroLase Therapy
|
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration
Time Frame: up to 6 months
|
Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response in Targeted Tumors.
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
February 19, 2009
First Submitted That Met QC Criteria
February 19, 2009
First Posted (Estimate)
February 20, 2009
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
December 19, 2016
Last Verified
December 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBI-07-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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