Liver MetastasisPhase 2NCT00083785
Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
A Phase 2 study testing Talaporfin sodium (LS11), LED-based light infusion device and Light emitting diodes (LED) in people with Liver Metastasis and Colorectal Neoplasms, run by Light Sciences LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis, Colorectal Neoplasms, Liver Neoplasms
- What is being tested?
- Talaporfin sodium (LS11), LED-based light infusion device and Light emitting diodes (LED)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to not given
- 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
- Patients with metastatic liver lesions from colorectal disease
- Biopsy proven evidence of colorectal cancer
- Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter
- Age greater than or equal to 18 years
- Patients must be able to sign informed consent
- Life expectancy greater than or equal to 3 months
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- ECOG performance status 0-2
- Patients with extrahepatic disease in addition to their hepatic metastases may be eligible
- Must have recovered from the toxicity from any prior antineoplastic therapy
Who cannot join
- Patients who are candidates for complete surgical resection
- Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment
- Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study
- PT or PTT greater than 1.5X control
- Platelet count less than 100,000
- WBC less than 2500/mm
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- Neutrophils less than 2000/mm
- Hemoglobin less than 9 g/dL
- Liver enzymes (AST, ALT, GGT, alkaline phosphatase) greater than 3 X ULN
- Total bilirubin greater than 1.5 X ULN
- Serum creatinine greater than 2.5 X ULN
- Patients who have been treated with either AVASTIN™ (Bevacizumab) or ERBITUX™ (Cetuximab) within the previous 4 weeks (28 days)
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
The purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.
Read the detailed description
Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions.
Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.
- Being tested
- Talaporfin sodium (LS11), LED-based light infusion device, Light emitting diodes (LED), Photodynamic therapy, Phototherapy
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talaporfin sodium (LS11)Drug
LED-based light infusion deviceDevice
Light emitting diodes (LED)Device
Photodynamic therapyProcedure or surgery
PhototherapyProcedure or surgery
ChemotherapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2004 (estimated)
- Study startMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasisStudies 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
- 25 participants
Sponsor and investigators
- Lead sponsor
- Light Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083785
- Sponsor's protocol ID
- LSC-OL003
- Status last verified
- Apr 2007
- First submitted
- 2 Jun 2004
- Last updated
- 11 Apr 2007
- Results posted
- No
Publications
Lustig RA, Vogl TJ, Fromm D, Cuenca R, Alex Hsi R, D'Cruz AK, Krajina Z, Turic M, Singhal A, Chen JC. A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors. Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708.
PubMed 14534895Chen J, Keltner L, Christophersen J, Zheng F, Krouse M, Singhal A, Wang SS. New technology for deep light distribution in tissue for phototherapy. Cancer J. 2002 Mar-Apr;8(2):154-63. doi: 10.1097/00130404-200203000-00009.
PubMed 11999949
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Treating Cancers With the Litx™ System and Chemotherapy. Section A: Phase II Safety and Effectiveness Study in Patients With Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00083785
- Acronym / sponsor ID
- LSC-OL003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Light Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 3 Jun 2004 (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 purpose of this study is to determine whether the Litx™ system is safe and effective in combination with chemotherapy in the treatment of liver metastasis arising from colorectal cancer. Litx™ is a next-generation photodynamic therapy platform in which the drug, talaporfin sodium (LS11), is activated by light from the light-emitting diode (LED)-based light infusion device, inserted directly into the tumor through the skin prior to treatment.
Detailed description
Patients that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single, two, three, or four Light Sources depending on their tumor characteristics. No more than 4 Light Sources will be used at a single treatment. The Light Sources may be used in a single lesion or in multiple lesions.
Following radiographic confirmation of Light Source placement, patients will receive an intravenous dose of LS11 at 40 mg/m². Fifteen minutes to 1 hour following completion of LS11 administration, delivery of 200 J/cm at 20 mW/cm light energy will begin. The Light Source will then be manually removed and the patients will be observed for acute complication of Light Source removal. Precautions for protection from external light exposure should be instituted beginning with the LS11 administration and be maintained as defined throughout the study period. On day 3 following Litx™ treatment the patient will receive a standard chemotherapy with Irinotecan or Oxaliplatin with or without 5FU and /or leucovorin for metastatic colorectal cancer. On day 30+5 and day 60+5 the patient will undergo clinical assessment and the tumor mass will be imaged using contrast enhanced spiral CT for determination of volume and radius of PDT necrosis.
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 (9 listed)
- Patients with metastatic liver lesions from colorectal disease
- Biopsy proven evidence of colorectal cancer
- Patients with 4 or fewer lesions greater than 1 cm and with no single lesion greater than 7 cm in maximum diameter
- Age greater than or equal to 18 years
- Patients must be able to sign informed consent
Key exclusion criteria (12 listed)
- Patients who are candidates for complete surgical resection
- Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment
- Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study
- PT or PTT greater than 1.5X control
- Platelet count less than 100,000
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 |
|---|---|---|
| Talaporfin sodium (LS11) | Drug | – |
| LED-based light infusion device | Device | – |
| Light emitting diodes (LED) | Device | – |
| Photodynamic therapy | Procedure or surgery | – |
| Phototherapy | Procedure or surgery | – |
| Chemotherapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 11 Apr 2007.
- Background: PubMed 14534895Lustig RA, Vogl TJ, Fromm D, Cuenca R, Alex Hsi R, D'Cruz AK, Krajina Z, Turic M, Singhal A, Chen JC. A multicenter Phase I safety study of intratumoral photoactivation of talaporfin sodium in patients with refractory solid tumors. Cancer. 2003 Oct 15;98(8):1767-71. doi: 10.1002/cncr.11708.
- Background: PubMed 11999949Chen J, Keltner L, Christophersen J, Zheng F, Krouse M, Singhal A, Wang SS. New technology for deep light distribution in tissue for phototherapy. Cancer J. 2002 Mar-Apr;8(2):154-63. doi: 10.1097/00130404-200203000-00009.
- Sponsor websiteLink provided by the sponsor.
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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.
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 Talaporfin sodium (LS11), LED-based light infusion device and Light emitting diodes (LED) in people with Liver Metastasis and Colorectal Neoplasms, run by Light Sciences LLC 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 9 inclusion and 12 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 11 Apr 2007. 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.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00083785, which also lists 2 linked publications.
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 11 Apr 2007.