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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Device: AuroLase Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AuroShell-3.5<br>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 | Device: AuroLase Therapy<br>* Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions<br>|
| Active Comparator: AuroShell-4.5<br>Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 4.5 watts. Device: AuroLase Therapy | Device: AuroLase Therapy<br>* Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions<br>|
| Active Comparator: AuroShell-5.0<br>Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 5.0 watts. Device: AuroLase Therapy | Device: AuroLase Therapy<br>* Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions<br>|

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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Response in Targeted Tumors. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, head and neck, laser, ablation