Study of the Litx™ System Combined With Chemotherapy in Patients With Colorectal Liver Metastases
NCT ID: NCT00083785
Last Updated: 2007-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Talaporfin sodium (LS11)
LED-based light infusion device
Light emitting diodes (LED)
Photodynamic therapy
Phototherapy
Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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 may be eligible
* Must have recovered from the toxicity from any prior antineoplastic therapy
Exclusion Criteria
* 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 (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)
18 Years
ALL
No
Sponsors
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Light Sciences LLC
INDUSTRY
Locations
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Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Chen 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.
Related Links
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Sponsor website
Other Identifiers
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LSC-OL003
Identifier Type: -
Identifier Source: org_study_id