- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01679470
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
November 2, 2016 updated by: Nanospectra Biosciences, Inc.
A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
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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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19124
- Cancer Treatment Centers of America Eastern Regional Medical Center
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants not manifesting a thermal lesion
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Glenn Goodrich, PhD, Nanospectra Biosciences
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
October 1, 2012
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
August 13, 2012
First Submitted That Met QC Criteria
August 31, 2012
First Posted (Estimate)
September 6, 2012
Study Record Updates
Last Update Posted (Estimate)
November 3, 2016
Last Update Submitted That Met QC Criteria
November 2, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBI-LC-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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