NCT00068068

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 8, 2003

Completed
23 days until next milestone

Study Start

First participant enrolled

October 1, 2003

Completed
Last Updated

September 19, 2006

Status Verified

September 1, 2006

First QC Date

September 4, 2003

Last Update Submit

September 18, 2006

Conditions

Liver MetastasisColorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis

Keywords

Photodynamic therapyLiver metastasesColorectal cancerLitx™Light Infusion Technology™Talaporfin sodiumLS11Liver metsMetastatic colorectal cancerLight emittting diodes (LED)Tumor ablationCombination therapy

Interventions

Talaporfin sodium (LS11)DRUG
LED-based light infusion deviceDEVICE
Light emitting diodes (LED)DEVICE
Photodynamic therapyPROCEDURE
PhototherapyPROCEDURE
ChemotherapyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HealthOne Alliance/Presbyterian St. Lukes Medical Center

Denver, Colorado, 80218, United States

Location

Eastern Carolina University, School of Medicine

Greenville, North Carolina, 27858, United States

Location

University of Pennsylvania / Department of Radiation Oncology

Philadelphia, Pennsylvania, 19104, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University Hospital Frankfurt, Johann Wolfgang Goethe-University

Frankfurt am Main, D-60596, Germany

Location

Related 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. doi: 10.1097/00130404-200203000-00009.

    PMID: 11999949BACKGROUND

  • 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.

    PMID: 14534895BACKGROUND

Related Links

MeSH Terms

Conditions

Colorectal NeoplasmsLiver NeoplasmsNeoplasm Metastasis

Interventions

TalaporfinPhotochemotherapyPhototherapyDrug Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 4, 2003

First Posted

September 8, 2003

Study Start

October 1, 2003

Last Updated

September 19, 2006

Record last verified: 2006-09

Locations

US(5)DE(1)