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NCT00028405 · ClinicalTrials.gov registry record · Phase 1

Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

A Phase 1 study, sponsored by Light Sciences.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target

NCT00028405 is a Phase 1 study that has completed, run by Light Sciences. The registered enrollment target is 48 participants.

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The verdict

NCT00028405, a Phase 1 study, has completed, sponsored by Light Sciences.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

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.

Interventions

  • DRUG LS 11(Taporfin Sodium)
  • DEVICE Lumaflex Light Delivery Catheter

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2001-11
Est. Completion 2002-12
Phase Phase 1

Sponsor

Light Sciences

5 total trials

What the Registry Record Tells You About NCT00028405

The ClinicalTrials.gov registry entry for NCT00028405 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Light Sciences, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which LS 11(Taporfin Sodium) is the first listed.

NCT00028405 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00028405 about?

NCT00028405 is a clinical study titled "Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors". 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 curren...

What is the current status of trial NCT00028405?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2001-11. Estimated completion is 2002-12.

What interventions are being tested in trial NCT00028405?

The interventions under investigation include: LS 11(Taporfin Sodium) (DRUG), Lumaflex Light Delivery Catheter (DEVICE).

Who is sponsoring clinical trial NCT00028405?

This trial is sponsored by Light Sciences, which has 5 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.