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Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

NCT00028405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2005-06-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

LS 11(Taporfin Sodium)

DEVICE

Lumaflex Light Delivery Catheter

Sponsors & Collaborators

  • Light Sciences LLC

    lead INDUSTRY

Principal Investigators

  • Jay Winship, MD · Sr. Vice President of R & D and Chief Medical Officer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-11-30
Completion
2002-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00028405 on ClinicalTrials.gov