Primary or Metastatic Lung TumorsNCT01679470
Efficacy Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
A study testing AuroLase Therapy in people with Primary or Metastatic Lung Tumors, run by Nanospectra Biosciences, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary or Metastatic Lung Tumors
- What is being tested?
- AuroLase Therapy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Treatment Centers of America Eastern Regional Medical Center
Philadelphia, Pennsylvania, 19124
About this study
Official title: 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.
- Conditions
- Primary or Metastatic Lung Tumors
- Being tested
- AuroLase Therapy
- Keywords
- cancer, lung, laser, ablation, airway obstruction
- Medical subject headings
- Lung Neoplasms, Neoplasms, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuroLase TherapyDevice
Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants not manifesting a thermal lesion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary or Metastatic Lung TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanospectra Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Goodrich, PhD, Study director, Nanospectra Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679470
- Sponsor's protocol ID
- NBI-LC-001
- Status last verified
- Nov 2016
- First submitted
- 13 Aug 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of AuroLase Therapy in Subjects With Primary and/or Metastatic Lung Tumors
- ClinicalTrials.gov ID
- NCT01679470
- Acronym / sponsor ID
- NBI-LC-001
- Conditions
- Primary or Metastatic Lung Tumors
- Keywords
- cancer, lung, laser, ablation, airway obstruction
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Nanospectra Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AuroLase TherapyInfusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions. | Device | – |
Primary outcome
Number of participants not manifesting a thermal lesion
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn Goodrich, PhD study director
Nanospectra Biosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AuroLase Therapy in people with Primary or Metastatic Lung Tumors, run by Nanospectra Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants not manifesting a thermal lesion (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.