Head and Neck CancerNCT00848042
Pilot Study of AuroLase(tm) Therapy in Refractory and/or Recurrent Tumors of the Head and Neck
A study testing AuroLase Therapy in people with Head and Neck Cancer, run by Nanospectra Biosciences, Inc. at 2 sites in United States.
Trial summary
This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3) treatment groups of five (5) patients each will be enrolled and observed for six (6) months following treatment. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- AuroLase Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have documented histological or cytological evidence of tumor(s) of the head and neck
- Patients must have one or more refractory and/or recurrent tumors of the head and neck which have at least one dimension with longest diameter 15 mm using conventional techniques or 10 mm with spiral CT scan.
- Target lesions should be accessible to examination (examination by fiber optic nasopharyngoscopy or laryngoscopy is permitted) and to biopsy.
- Each index lesion should be large enough to provide at least 6 mg of tumor tissue by biopsy (such as an 18 gauge Tru-Cut needle biopsy 1cm in length or similar technique) for assessment by neutron activation analysis.
- Tumors must be measurable according to RECIST criteria
- Patients must be ≥ 18 years of age
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- Patients must have ECOG Performance Score of 0, 1 or 2 (see Appendix 3)
- Patients 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
- Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold)
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Patients who are pregnant and/or lactating
- Patients 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
- Patients who have undergone splenectomy
- Patient who has had a course of radiotherapy in the treatment area within the past 30 days.
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- Patient who has had a course of chemotherapy or other anti-neoplastic therapy in the past 30 days.
- Patient who has had surgery within 2 cm of the treatment area within the past two weeks.
- 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 patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Treatment Centers of American Western Regional Medical Center
Goodyear, Arizona, 85338
Baylor College of Medicine
Houston, Texas, 77030
About this study
Official title: A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck
This is an open-label, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3) treatment groups of five (5) patients each will be enrolled and observed for six (6) months following treatment. Each group will receive a single dose of AuroShell(TM) particles followed by one or more interstitial illuminations with an 808nm laser. Particle dose and laser power may be increased in each dosing group.
- Conditions
- Head and Neck Cancer
- Being tested
- AuroLase Therapy
- Keywords
- cancer, head and neck, laser, ablation
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
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
| Study group | Role | What they receive |
|---|---|---|
| AuroShell-3.5 | Active comparator | Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 3.5 watts. Device: AuroLase Therapy Receives: Device: AuroLase Therapy |
| AuroShell-4.5 | Active comparator | Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 4.5 watts. Device: AuroLase Therapy Receives: Device: AuroLase Therapy |
| AuroShell-5.0 | Active comparator | Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 5.0 watts. Device: AuroLase Therapy Receives: Device: AuroLase Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration
Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion
Measured: up to 6 months
Secondary outcomes (1)
Response in Targeted Tumors.
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 posted20 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanospectra Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848042
- Sponsor's protocol ID
- NBI-07-001
- Status last verified
- Dec 2016
- First submitted
- 19 Feb 2009
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of AuroLase(tm) Therapy in Patients With Refractory and/or Recurrent Tumors of the Head and Neck
- ClinicalTrials.gov ID
- NCT00848042
- Acronym / sponsor ID
- NBI-07-001
- Conditions
- Head and Neck Cancer
- Keywords
- cancer, head and neck, laser, ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nanospectra Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Posted 18 Jul 2016
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, multicenter, single-dose pilot study of AuroLase(TM) Therapy in the treatment of patients with refractory and/or recurrent tumors of the head and neck. Three (3) treatment groups of five (5) patients each will be enrolled and observed for six (6) months following treatment. Each group will receive a single dose of AuroShell(TM) particles followed by one or more interstitial illuminations with an 808nm laser. Particle dose and laser power may be increased in each dosing group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AuroShell-3.5 | Active comparator | Device: AuroLase TherapyGroup treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 3.5 watts. Device: AuroLase Therapy |
| AuroShell-4.5 | Active comparator | Device: AuroLase TherapyGroup treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 4.5 watts. Device: AuroLase Therapy |
| AuroShell-5.0 | Active comparator | Device: AuroLase TherapyGroup treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 optical density and 5.0 watts. Device: AuroLase Therapy |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have documented histological or cytological evidence of tumor(s) of the head and neck
- Patients must have one or more refractory and/or recurrent tumors of the head and neck which have at least one dimension with longest diameter 15 mm using conventional techniques or 10 mm with spiral CT scan.
- Target lesions should be accessible to examination (examination by fiber optic nasopharyngoscopy or laryngoscopy is permitted) and to biopsy.
- Each index lesion should be large enough to provide at least 6 mg of tumor tissue by biopsy (such as an 18 gauge Tru-Cut needle biopsy 1cm in length or similar technique) for assessment by neutron activation analysis.
- Tumors must be measurable according to RECIST criteria
Key exclusion criteria (10 listed)
- Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold)
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in question prior to the day of dosing with the PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Patients who are pregnant and/or lactating
- Patients 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
- Patients who have undergone splenectomy
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 | AuroShell-3.5, AuroShell-4.5, AuroShell-5.0 |
Primary outcome
Number of Participants With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration
Time frame: up to 6 months
Includes all participants that experienced an adverse device effect that were rated probable or definitely related to AuroShell particle infusion
1 secondary outcome
Response in Targeted Tumors.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Head and Neck Cancer, run by Nanospectra Biosciences, Inc. at 2 sites 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 10 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: finished, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Any Adverse Device Effects Considered Attributable to AuroShell Particle Administration (time frame: up to 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 9 Feb 2017.