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Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases Clinical research trials and Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases clinical trial. Subjects frequently get the best healthcare possible for their Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases  Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
For Condition: Colorectal Neoplasms,Liver Metastasis,Liver Neoplasms,Neoplasm Metastasis
Status: Recruiting
Sponsor(s): Light Sciences Corporation ,
Synopsis: The purpose of this study is to determine whether the Litx platform is safe and effective 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.
Details: 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 infusion devices depending on their tumor characteristics. No more than 4 light sources will be used at a single treatment. The light infusion devices may be used in a single lesion or in multiple lesions. Following radiographic confirmation of light infusion device placement, patients will receive an intravenous dose of LS11 at 40 mg/m². One hour following completion of LS11 administration, delivery of 200 J/cm light energy will begin. The light infusion device will then be manually removed and the patients will be observed for acute complication of light infusion device 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 30+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 the tumor size, as well as tumor necrosis. The patient may then receive 5-FU and/or leucovorin + either irinotecan or oxaliplatin standard chemotherapy at day 30 visit. All patients, with or without chemotherapy at day 30, will undergo final clinical assessment and final tumor imaging evaluation using contrast CT at day 60+5 of Litx treatment.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Patients with metastatic liver lesions from colorectal disease who have failed or progressed on a chemotherapy regimen for metastatic 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. - ECOG performance status 0-2. - Patients with extrahepatic disease in addition to their hepatic metastases are eligible and will receive systemic therapy for their extrahepatic disease following Litx therapy. - Off chemotherapy for 4 weeks. Must have recovered from the chemotherapy effects. Exclusion Criteria Patients must be excluded if any of the following apply: - 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. - Neutrophils less than 2000/mm. - Hemoglobin less than 9 g/dL. - Liver enzymes greater than 3 X ULN. - Total bilirubin greater than 1.5 X ULN. - Serum creatinine greater than 2.5 X ULN.
Total Enrollment: 25
Location and Contact Information:
Allegheny General Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15212
United States
Recruiting Barbara Early 412-359-6498
University Hospital Frankfurt, Johann Wolfgang Goethe-University *Recruiting*
Frankfurt am Main, , D-60596
Germany
Recruiting Kerstin Engelmann 49-69-6301-7292
University of Pennsylvania / Department of Radiation Oncology *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Marie Gardler 215-662-7449
HealthOne Alliance/Presbyterian St. Lukes Medical Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Ken Dole 303-788-4806
Virginia Mason Medical Center *Recruiting*
Seattle, Washington, 98101
United States
Recruiting Layle Smith 206-583-6559
Additional Information:
Study ID Numbers: LSC-OL002;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00068068
Other Neoplasm Metastasis Studies:
1. Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
2. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
Related Studies:
Other Neoplasm Metastasis Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Photodynamic therapy with talaporfin sodium (LS11) in treating patients with refractory colorectal liver metastases
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