Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

June 23, 2005 updated by: Light Sciences LLC

A Multicenter Phase I Safety and Tolerability Study of the Oncolux System for Intratumoral Delivery of Non-Coherent Light for the Photoactivation of LS 11 in Patients With Refractory 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 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this Phase I photodynamic therapy study, patients will undergo a standard CT scan to determine the suitability of the treatment. In those patients that qualify the entry criteria, a light delivery catheter will be directly inserted in the tumor through a minor surgical procedure. The patients will then be injected with the photosensitive drug, LS11. One hour following the drug injection, light energy will be delivered from the light delivery catheter for a period of 1-24 hours. The duration of the light treatment for a given patient may be based on various factors including when a given patient enters the study. Following the delivery of light energy, the light delivery catheter will be removed from the tumor. The insertion and removal of the catheter will be carried out under the guidance of CT scan. The patients will be asked to take precautions from external light exposure for a period of time. The patients will undergo CT scan and other tests on days 7, 14 and 42 to evaluate safety of the treatment, tumor cell death and treatment response. Blood samples will be taken at different time points to examine the clearance of the drug from the body.

Study Type

Interventional

Enrollment

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • University of Arizona, VA Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center, Wayne State University
    • North Carolina
      • Greenville, North Carolina, United States, 27858
        • East Carolina State University, Brody School of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Primary Inclusion Criteria:

  • Target tumors accessible for percutaneous implantation under CT (and ultrasound if needed) guidance in any superficial location, sarcoma, tumors of oral/oro-pharyngeal cavity, tumors with extensive pelvic involvement, or liver metastasis.
  • Patient has failed prior surgery or chemotherapy or radiation therapy and the tumor is refractory.
  • Tumor mass is not immediately adjacent to, or directly invading a major vessel or hollow viscus such that tumor necrosis could result in hemorrhage or perforation.
  • Patient has not received prior chemotherapy for at least 4 weeks and patient has recovered from toxicity.
  • Patient has an ECOG performance status of 0-3 (Karnofsky 30 or higher).
  • If patients have received radiotherapy to sites of disease other than the one planned for insertion of the light delivery catheter, then the patient must have no current local or systemic toxicity from the prior radiation.
  • Patient has recovered from all previous surgery in the judgment of the Principal Investigator.
  • Patient has not been treated with any biologics (excluding hormones) at least 4 weeks prior to the screening and patient has recovered from any toxicity.
  • Age 18 or older.
  • Minimum life expectancy of 12 weeks.
  • Ability to provide informed consent.

  • All tumors must:

    • have a minimum dimension that exceeds 4 x 2.8 cm;
    • have a shape and location such that the mid-point on the light delivery catheter will be greater than 2.0 cm from any structure which, if damaged by PDT treatment, would result in pain or injury to the patient.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Light Sciences LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion

December 1, 2002

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 8, 2002

First Posted (Estimate)

January 9, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSC-OL001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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