Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
Verified October 2012 by Nanospectra Biosciences, Inc.
Information provided by (Responsible Party):
Nanospectra Biosciences, Inc.
First received: August 13, 2012
Last updated: October 23, 2012
Last verified: October 2012
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.
Primary or Metastatic Lung Tumors
Device: AuroLase Therapy
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
Primary Outcome Measures:
- Number of participants not manifesting a thermal lesion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2013 (Final data collection date for primary outcome measure)
Device: AuroLase Therapy
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679470
|Cancer Treatment Centers of America Eastern Regional Medical Center
|Philadelphia, Pennsylvania, United States, 19124 |
|Contact: Martha Bilyk, RN 215-537-6438 firstname.lastname@example.org |
|Principal Investigator: Mark Lund, MD |
Nanospectra Biosciences, Inc.
||Glenn Goodrich, PhD
No publications provided
||Nanospectra Biosciences, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 13, 2012
||October 23, 2012
||United States: Food and Drug Administration
Keywords provided by Nanospectra Biosciences, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Respiratory Tract Neoplasms
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