GliomaPhase 2NCT00409214
Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
A Phase 2 study testing LS11 (talaporfin sodium), Light source (interstitial light emitting diodes) and Intraoperative placement of device in glioma in people with Glioma and Glioblastoma Multiforme, run by Light Sciences Oncology at 1 site in Serbia.
Trial summary
The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- What is being tested?
- LS11 (talaporfin sodium), Light source (interstitial light emitting diodes) and Intraoperative placement of device in glioma
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 18 participants
- Where
- 1 siteSerbia
- Study dates
- Nov 2006to Feb 2008
- Phase
- Phase 2
- 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
- Have primary or recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) undergoing planned tumor resection
- Have a right sided, supratentorial frontal or temporal lobe tumor
- Have right hand dominance
- Be adults aged >18 years
- Have a Karnofsky Performance Status score >70
- Have a estimated life expectancy of >12 weeks
Show all 10Show fewer
- Have completed any prior antineoplastic therapy at least 4 weeks prior to surgery and be recovered from acute side effects
- Must have the understanding and ability to sign an informed consent document
- Be male or non-pregnant, non-lactating females. Patients who are fertile must agree to use an effective method of contraception during participation in the study
- Have a negative serum or urine pregnancy test within 14 days prior to treatment (if patient is a female of childbearing potential).
Who cannot join
- Patients must be excluded if any of the following apply:
- Have tumors <2 cm in diameter
- Have inadequate organ function as evidenced by: PT or PTT >1.5 × control ; Platelet count <100,000/mm3 ; WBC <2,500/mm3 ; Neutrophils <2000/mm3 ; Hemoglobin <9 g/dL
- Be concurrently participating in another clinical trial involving experimental treatment
- Have any concurrent diseases or conditions that in the opinion of the investigator impair the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded.
- Have psychological, familial, sociological, geographical, or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial data.
- Have a known sensitivity to porphyrin-type drugs or known history of porphyria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma (Defined for the Purposes of the Protocol as Anaplastic Astrocytoma [AA] or Glioblastoma Multiforme [GBM]) Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.
Read the detailed description
Light Infusion Technology (Litx™) is a locoregional cancer treatment in which a systemically administered light-activated drug (LS11) is activated locally by illuminating the diseased tissue using light-emitting diodes (LEDs) of a specific wavelength. The activated photosensitizer reacts with endogenous oxygen to yield highly reactive species of oxygen that cause destruction of cellular structures such as mitochondria, lysosomes and cell walls leading to irreversible cell damage and tissue death.
Either twenty-four or twelve hours prior to surgery, the patient will receive an intravenous dose of 1 mg/kg of LS11, given IV by slow push over 3-5 minutes.
Following craniotomy, patients will undergo intraoperative placement of a single Light Source, centrally placed within the tumor, under direct visualization prior to tumor resection. Following placement of the light source (with the depth of the end of the light bar from the cortical surface to be calculated from the pre-operative MRI and spiral CT scan, so as to be centralized within the main tumor bulk), light will be delivered following a predetermined escalation schedule (either 100 J/cm or 200 J/cm) at 20 mW/cm light energy for a treatment time of 1 hour 24 minutes (100J/cm) or 2 hours 46 minutes (200 J/cm). The Light Source will then be manually removed and the tumor maximally resected.
The resected tumor and marginal tissue will be submitted for pathology to determine depth of cell death, extent of tumor tissue containing closed vessels, any evidence of vessel closure or other damage to tissues outside of the projected kill zone.
- Conditions
- Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- Being tested
- LS11 (talaporfin sodium), Light source (interstitial light emitting diodes), Intraoperative placement of device in glioma
- Keywords
- Glioma, Litx™, LS11, Glioblastoma multiforme, Anaplastic Astrocytoma, GBM, AA
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS11 (talaporfin sodium)Drug
Light source (interstitial light emitting diodes)Device
Intraoperative placement of device in gliomaProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Light Sciences Oncology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sy-Shi Wang, PhD, Study director, Light Sciences Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409214
- Sponsor's protocol ID
- LSO-OL007
- Status last verified
- Nov 2012
- First submitted
- 7 Dec 2006
- Last updated
- 16 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma (Defined for the Purposes of the Protocol as Anaplastic Astrocytoma [AA] or Glioblastoma Multiforme [GBM]) Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
- ClinicalTrials.gov ID
- NCT00409214
- Acronym / sponsor ID
- LSO-OL007
- Conditions
- Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- Keywords
- Glioma, Litx™, LS11, Glioblastoma multiforme, Anaplastic Astrocytoma, GBM, AA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Light Sciences OncologyIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Feb 2008 (actual)
- First posted
- 8 Dec 2006 (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.
The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.
Detailed description
Light Infusion Technology (Litx™) is a locoregional cancer treatment in which a systemically administered light-activated drug (LS11) is activated locally by illuminating the diseased tissue using light-emitting diodes (LEDs) of a specific wavelength. The activated photosensitizer reacts with endogenous oxygen to yield highly reactive species of oxygen that cause destruction of cellular structures such as mitochondria, lysosomes and cell walls leading to irreversible cell damage and tissue death.
Either twenty-four or twelve hours prior to surgery, the patient will receive an intravenous dose of 1 mg/kg of LS11, given IV by slow push over 3-5 minutes.
Following craniotomy, patients will undergo intraoperative placement of a single Light Source, centrally placed within the tumor, under direct visualization prior to tumor resection. Following placement of the light source (with the depth of the end of the light bar from the cortical surface to be calculated from the pre-operative MRI and spiral CT scan, so as to be centralized within the main tumor bulk), light will be delivered following a predetermined escalation schedule (either 100 J/cm or 200 J/cm) at 20 mW/cm light energy for a treatment time of 1 hour 24 minutes (100J/cm) or 2 hours 46 minutes (200 J/cm). The Light Source will then be manually removed and the tumor maximally resected.
The resected tumor and marginal tissue will be submitted for pathology to determine depth of cell death, extent of tumor tissue containing closed vessels, any evidence of vessel closure or other damage to tissues outside of the projected kill zone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- 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 (10 listed)
- Have primary or recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA) undergoing planned tumor resection
- Have a right sided, supratentorial frontal or temporal lobe tumor
- Have right hand dominance
- Be adults aged >18 years
- Have a Karnofsky Performance Status score >70
Key exclusion criteria (7 listed)
- Have tumors <2 cm in diameter
- Have inadequate organ function as evidenced by: PT or PTT >1.5 × control ; Platelet count <100,000/mm3 ; WBC <2,500/mm3 ; Neutrophils <2000/mm3 ; Hemoglobin <9 g/dL
- Be concurrently participating in another clinical trial involving experimental treatment
- Have any concurrent diseases or conditions that in the opinion of the investigator impair the patient's ability to complete the trial such as psychological, familial, sociological, geographical or medical conditions which in the Principal Investigator's opinion could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial's data are excluded.
- Have psychological, familial, sociological, geographical, or medical conditions which, in the Investigator's opinion, could compromise compliance with the objectives and procedures of this protocol or obscure interpretation of the trial data.
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 |
|---|---|---|
| LS11 (talaporfin sodium) | Drug | – |
| Light source (interstitial light emitting diodes) | Device | – |
| Intraoperative placement of device in glioma | Procedure or surgery | – |
Primary outcome
To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2012.
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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.
Sy-Shi Wang, PhD study director
Light Sciences Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LS11 (talaporfin sodium), Light source (interstitial light emitting diodes) and Intraoperative placement of device in glioma in people with Glioma and Glioblastoma Multiforme, run by Light Sciences Oncology at 1 site in Serbia.
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 10 inclusion and 7 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 16 Nov 2012. 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 Serbia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma. 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 16 Nov 2012.