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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAuroLase Therapy

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 3, 2016 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Nanospectra Biosciences, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Nanospectra Biosciences, Inc.
Interventions being studied: Device: AuroLase Therapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Cancer Treatment Centers of America Eastern Regional Medical CenterPhiladelphia, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 3, 2016. Always confirm current availability with the study team.

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