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

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

Tracking Information
First Submitted Date  ICMJE August 13, 2012
First Posted Date  ICMJE September 6, 2012
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Number of participants not manifesting a thermal lesion [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Primary or Metastatic Lung Tumors
Intervention  ICMJE Device: AuroLase Therapy
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 2, 2016)
1
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
25
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679470
Other Study ID Numbers  ICMJE NBI-LC-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanospectra Biosciences, Inc.
Study Sponsor  ICMJE Nanospectra Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Glenn Goodrich, PhD Nanospectra Biosciences
PRS Account Nanospectra Biosciences, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP