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

• 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: Nanospectra Biosciences, Inc.
• Information provided by (Responsible Party): Nanospectra Biosciences, Inc.

Tracking Information

• First Submitted Date: February 19, 2009
• First Posted Date: February 20, 2009
• Results First Submitted Date: June 7, 2016
• Results First Posted Date: July 18, 2016
• Last Update Posted Date: February 9, 2017
• Study Start Date: April 2008
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 20, 2016)

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

• Original Primary Outcome Measures (submitted: February 19, 2009): •Determination of any adverse device effects attributable to AuroShell particle administration [ Time Frame: 6 months ]
• Current Secondary Outcome Measures (submitted: June 7, 2016): Response in Targeted Tumors. [ Time Frame: 6 months ]
• Original Secondary Outcome Measures (submitted: February 19, 2009): Response in targeted tumors. [ Time Frame: 6 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck
• Official Title: A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• 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

Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions

Study Arms

• 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
  Intervention: Device: AuroLase Therapy
• 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
  Intervention: Device: AuroLase Therapy
• 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
  Intervention: Device: AuroLase Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2014): 11
• Original Estimated Enrollment (submitted: February 19, 2009): 15
• Actual Study Completion Date: August 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 130 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00848042
• Other Study ID Numbers: NBI-07-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nanospectra Biosciences, Inc.
• Original Responsible Party: JD Payne, President, Nanospectra Biosciences, Inc.
• Current Study Sponsor: Nanospectra Biosciences, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nanospectra Biosciences, Inc.
• Verification Date: December 2016