Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

Completed · Phase 1

Conditions studied: Liver Metastasis, Pelvic Cancer, Head and Neck Cancer, Sarcoma, Rectal Cancer, Breast Cancer, Colorectal Cancer, Mouth Cancer

In brief

This multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis. The treatment is limited to patients that have failed to respond to currently approved methods of treatment. The study involves a single, intravenous administration of an investigational drug, LS11 (previously studied in approximately 80 cancer patients) and the placement of a novel, flexible light delivery catheter inside the tumor by a minor surgical procedure. The activation of LS11 by the light delivery catheter over a period of 1-24 hrs may result in destruction of tumor tissue.

Key facts

Study ID

NCT00028405

Run by

Light Sciences LLC

People needed

48

Starts

2001-11-01

Expected to finish

2002-12-01

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• History of cardiovascular abnormalities, including, myocardial infarction in the last 6 months, arrhythmias, uncontrolled congestive heart failure;
• History of ongoing, significant active medical illness that might create a risk for the patient, in the opinion of the Investigator;
• History of known or suspected porphyria;
• Concomitant use of other drugs known to produce skin photosensitivity;
• Women who are pregnant or lactating;
• Hematopoietic abnormalities from the baseline examination, as evidenced by the following laboratory values (US Units):Hemoglobin <10 g/dL; White blood cell (WBC) count <2500/mm3;Neutrophil count < or = 1500/uL;Platelet count < or = 100,000/mm3;
• Renal or liver function abnormalities from the baseline examination, as evidenced by the following laboratory values(US Units):Serum Creatinine >2.0 mg/dL;Total bilirubin > 2.0 mg/dL; SGOT (AST) > 3x the ULN;SGPT (ALT) > 3x the ULN; GGT> 3x the ULN

Where it is running

• University of Arizona, VA Medical Center — Tucson, Arizona, United States
• Detroit Medical Center, Wayne State University — Detroit, Michigan, United States
• East Carolina State University, Brody School of Medicine — Greenville, North Carolina, United States
• University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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