Photodynamic Therapy With Talaporfin Sodium (LS11) in Treating Patients With Refractory Colorectal Liver Metastases

Colorectal Neoplasms Clinical Trial

Official title:

Safety and Efficacy of Treating Refractory Cancers With the Litx™ System: Phase II Safety and Efficacy Study in Patients With Liver Metastases From Colorectal Cancer That Have Failed Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00068068
• Other study ID #: LSC-OL002
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2003
• Last updated: September 18, 2006
• Start date: October 2003

Study information

• Verified date: September 2006
• Source: Light Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00078871

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neoplasms, Second Primary

Intervention

Drug:
• Talaporfin sodium (LS11)

Device:
• LED-based light infusion device

• Light emitting diodes (LED)

Procedure:
• Photodynamic therapy

• Phototherapy

• Chemotherapy

Locations

Country	Name	City	State
Germany	University Hospital Frankfurt, Johann Wolfgang Goethe-University	Frankfurt am Main
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Light Sciences LLC

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation