Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

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Brief Title

Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

Official Title

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

Brief 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.

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 Phase

Phase 1

Study Type



Liver Metastasis


LS 11(Taporfin Sodium)


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

November 2001

Completion Date

December 2002

Eligibility Criteria

        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

          -  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

          -  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




18 Years - N/A

Accepts Healthy Volunteers



Jay Winship, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Study Sponsor

Light Sciences LLC

Study Sponsor

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

Verification Date

March 2003