Liver MetastasisPhase 1NCT00028405
Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors
A Phase 1 study testing LS 11(Taporfin Sodium) and Lumaflex Light Delivery Catheter in people with Liver Metastasis and Pelvic Cancer, run by Light Sciences LLC at 6 sites in United States.
Trial summary
This multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis, Pelvic Cancer, Head and Neck Cancer
- What is being tested?
- LS 11(Taporfin Sodium) and Lumaflex Light Delivery Catheter
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2001to Dec 2002
- Phase
- Phase 1
- 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
None listed.
Who cannot join
- History of cardiovascular abnormalities, including, myocardial infarction in the last 6 months, arrhythmias, uncontrolled congestive heart failure;
- History of ongoing, significant active medical illness that might create a risk for the patient, in the opinion of the Investigator;
- History of known or suspected porphyria;
- Concomitant use of other drugs known to produce skin photosensitivity;
- Women who are pregnant or lactating;
- Hematopoietic abnormalities from the baseline examination, as evidenced by the following laboratory values (US Units):Hemoglobin <10 g/dL; White blood cell (WBC) count <2500/mm3;Neutrophil count < or = 1500/uL;Platelet count < or = 100,000/mm3;
- Renal or liver function abnormalities from the baseline examination, as evidenced by the following laboratory values(US Units):Serum Creatinine >2.0 mg/dL;Total bilirubin > 2.0 mg/dL; SGOT (AST) > 3x the ULN;SGPT (ALT) > 3x the ULN; GGT> 3x the ULN
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Detroit Medical Center, Wayne State University
Detroit, Michigan, 48201
East Carolina State University, Brody School of Medicine
Greenville, North Carolina, 27858
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Virginia Mason Medical Center
Seattle, Washington, 98101
University of Arizona, VA Medical Center
Tucson, Arizona, 85723
About this study
Official title: A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory Solid Tumors
This multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis. The treatment is limited to patients that have failed to respond to currently approved methods of treatment. The study involves a single, intravenous administration of an investigational drug, LS11 (previously studied in approximately 80 cancer patients) and the placement of a novel, flexible light delivery catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.
Read the detailed description
In this Phase I photodynamic therapy study, patients will undergo a standard CT scan to determine the suitability of the treatment. In those patients that qualify the entry criteria, a light delivery catheter will be directly inserted in the tumor through a minor surgical procedure. The patients will then be injected with the photosensitive drug, LS11. One hour following the drug injection, light energy will be delivered from the light delivery catheter for a period of 1-24 hours. The duration of the light treatment for a given patient may be based on various factors including when a given patient enters the study. Following the delivery of light energy, the light delivery catheter will be removed from the tumor. The insertion and removal of the catheter will be carried out under the guidance of CT scan. The patients will be asked to take precautions from external light exposure for a period of time. The patients will undergo CT scan and other tests on days 7, 14 and 42 to evaluate safety of the treatment, tumor cell death and treatment response. Blood samples will be taken at different time points to examine the clearance of the drug from the body.
- Conditions
- Liver Metastasis, Pelvic Cancer, Head and Neck Cancer, Sarcoma, Rectal Cancer, Breast Cancer
- Being tested
- LS 11(Taporfin Sodium), Lumaflex Light Delivery Catheter
- Keywords
- Photodynamic Therapy, Bulky Tumor, Refractory Tumor, Head and Neck Cancer, Breast Cancer, Pelvic Tumors, Liver Metastasis, Colorectal Cancer, Sarcoma, Anal Cancer, Oral Cancer, Recurrent, Lymphadenopathy, Ovarian Cancer, Cervical Cancer
- Medical subject headings
- Pelvic Neoplasms, Head and Neck Neoplasms, Sarcoma, Rectal Neoplasms, Breast Neoplasms, Colorectal Neoplasms, Mouth Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LS 11(Taporfin Sodium)Drug
Lumaflex Light Delivery CatheterDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2002 (estimated)
- Study startNov 2001
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants
Sponsor and investigators
- Lead sponsor
- Light Sciences LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jay Winship, MD, Study director, Sr. Vice President of R & D and Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028405
- Sponsor's protocol ID
- LSC-OL001
- Status last verified
- Mar 2003
- First submitted
- 4 Jan 2002
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Taber SW, Fingar VH, Coots CT, Wieman TJ. Photodynamic therapy using mono-L-aspartyl chlorin e6 (Npe6) for the treatment of cutaneous disease: a Phase I clinical study. Clin Cancer Res. 1998 Nov;4(11):2741-6.
PubMed 9829737
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00028405
- Acronym / sponsor ID
- LSC-OL001
- Conditions
- Liver Metastasis, Pelvic Cancer, Head and Neck Cancer, Sarcoma, Rectal Cancer, Breast Cancer
- Keywords
- Photodynamic Therapy, Bulky Tumor, Refractory Tumor, Head and Neck Cancer, Breast Cancer, Pelvic Tumors, Liver Metastasis, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants
- Lead sponsor
- Light Sciences LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2001
- Study completion
- Dec 2002
- First posted
- 9 Jan 2002 (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 multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis. The treatment is limited to patients that have failed to respond to currently approved methods of treatment. The study involves a single, intravenous administration of an investigational drug, LS11 (previously studied in approximately 80 cancer patients) and the placement of a novel, flexible light delivery catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.
Detailed description
In this Phase I photodynamic therapy study, patients will undergo a standard CT scan to determine the suitability of the treatment. In those patients that qualify the entry criteria, a light delivery catheter will be directly inserted in the tumor through a minor surgical procedure. The patients will then be injected with the photosensitive drug, LS11. One hour following the drug injection, light energy will be delivered from the light delivery catheter for a period of 1-24 hours. The duration of the light treatment for a given patient may be based on various factors including when a given patient enters the study. Following the delivery of light energy, the light delivery catheter will be removed from the tumor. The insertion and removal of the catheter will be carried out under the guidance of CT scan. The patients will be asked to take precautions from external light exposure for a period of time. The patients will undergo CT scan and other tests on days 7, 14 and 42 to evaluate safety of the treatment, tumor cell death and treatment response. Blood samples will be taken at different time points to examine the clearance of the drug from the body.
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 (0 listed)
Key exclusion criteria (7 listed)
- History of cardiovascular abnormalities, including, myocardial infarction in the last 6 months, arrhythmias, uncontrolled congestive heart failure;
- History of ongoing, significant active medical illness that might create a risk for the patient, in the opinion of the Investigator;
- History of known or suspected porphyria;
- Concomitant use of other drugs known to produce skin photosensitivity;
- Women who are pregnant or lactating;
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 |
|---|---|---|
| LS 11(Taporfin Sodium) | Drug | – |
| Lumaflex Light Delivery Catheter | Device | – |
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 24 Jun 2005.
- Background: PubMed 9829737Taber SW, Fingar VH, Coots CT, Wieman TJ. Photodynamic therapy using mono-L-aspartyl chlorin e6 (Npe6) for the treatment of cutaneous disease: a Phase I clinical study. Clin Cancer Res. 1998 Nov;4(11):2741-6.
- Related InfoLink 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.
Jay Winship, MD study director
Sr. Vice President of R & D and Chief Medical Officer
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LS 11(Taporfin Sodium) and Lumaflex Light Delivery Catheter in people with Liver Metastasis and Pelvic Cancer, run by Light Sciences LLC at 6 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 0 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 NCT00028405, which also lists 1 linked publication.
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 24 Jun 2005.