Colorectal Neoplasms, Liver Metastasis, Liver Neoplasms, Neoplasm Metastasis
Conditions
Keywords
Photodynamic therapy, Liver metastases, Colorectal cancer, Litx™, Light Infusion Technology™, Talaporfin sodium, LS11, Liver mets, Metastatic colorectal cancer, Light emittting diodes (LED), Tumor ablation, Combination therapy
Brief summary
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.
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 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.
Interventions
PROCEDUREPhotodynamic therapy
PROCEDUREPhototherapy
PROCEDUREChemotherapy
Sponsors
Light Sciences LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Germany, United States
Outcome results
None listed