Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases
NCT ID: NCT00068068
Last Updated: 2006-09-19
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
2003-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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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 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 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.
18 Years
ALL
No
Sponsors
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Light Sciences LLC
INDUSTRY
Locations
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HealthOne Alliance/Presbyterian St. Lukes Medical Center
Denver, Colorado, United States
Eastern Carolina University, School of Medicine
Greenville, North Carolina, United States
University of Pennsylvania / Department of Radiation Oncology
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University Hospital Frankfurt, Johann Wolfgang Goethe-University
Frankfurt am Main, , Germany
Countries
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References
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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.
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.
Related Links
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Sponsor website
Other Identifiers
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LSC-OL002
Identifier Type: -
Identifier Source: org_study_id
NCT00078871
Identifier Type: -
Identifier Source: nct_alias