Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors

• ClinicalTrials.gov Identifier: NCT01679470
• Recruitment Status: Terminated
• First Posted: September 6, 2012
• Last Update Posted: November 3, 2016
• Sponsor: Nanospectra Biosciences, Inc.
• Information provided by (Responsible Party): Nanospectra Biosciences, Inc.

Tracking Information

• First Submitted Date: August 13, 2012
• First Posted Date: September 6, 2012
• Last Update Posted Date: November 3, 2016
• Study Start Date: October 2012
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 31, 2012): Number of participants not manifesting a thermal lesion [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
• Official Title: A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
• Brief Summary: This is an open-label, single-center, single-dose efficacy pilot study of AuroLase Therapy in the treatment of subjects with primary and/or metastatic tumors of the lung where there is airway obstruction. In this study patients will be given a systemic IV infusion of particles and a subsequent escalating dose of laser radiation delivered by optical fiber via bronchoscopy.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Primary or Metastatic Lung Tumors

Intervention

Device: AuroLase Therapy

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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 2, 2016): 1
• Original Estimated Enrollment (submitted: August 31, 2012): 25
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subjects must have documented histological or cytological evidence of tumor(s) of the lung.
• Subjects must have one or more primary or metastatic tumors of the lung which have at least 10 mm in long axis as evaluated by spiral CT scan evaluation performed within last 30 days.
• Target lesions should be accessible to examination (examination by fiberoptic bronchoscopy is permitted) and to biopsy.
• Each index lesion should be large enough to provide at least 6 mg of tumor tissue by biopsy for assessment by neutron activation analysis.
• Tumors must be measurable according to RECIST criteria.
• Subjects must have ECOG Performance Score of 0, 1 or 2.
• Subjects must be ≥ 18 years of age.
• Subjects 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:

• Subjects with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold).
• Patients who are pregnant and/or lactating.
• Patients who have undergone splenectomy.
• Subjects who are receiving concurrent investigational therapy or who have received investigational therapy within the 30 days prior to AuroShell infusion (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
• Subjects 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.
• Subject who has had a course of radiotherapy in the treatment area within the 30 days prior to AuroShell infusion.
• Subject who has had a course of chemotherapy or other anti-neoplastic therapy in the 30 days prior to AuroShell infusion.
• 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 subject'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 and older (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: NCT01679470
• Other Study ID Numbers: NBI-LC-001
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nanospectra Biosciences, Inc.
• Study Sponsor: Nanospectra Biosciences, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Glenn Goodrich, PhD; Nanospectra Biosciences

• PRS Account: Nanospectra Biosciences, Inc.
• Verification Date: November 2016