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Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors

This study has been completed.
Sponsor:
Information provided by:
Light Sciences LLC
ClinicalTrials.gov Identifier:
NCT00028405
First received: January 4, 2002
Last updated: June 23, 2005
Last verified: March 2003
  Purpose

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.


Condition Intervention Phase
Liver Metastasis
Pelvic Cancer
Head and Neck Cancer
Sarcoma
Rectal Cancer
Breast Cancer
Colorectal Cancer
Mouth Cancer
Drug: LS 11(Taporfin Sodium)
Device: Lumaflex Light Delivery Catheter
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Light Sciences LLC:

Estimated Enrollment: 48
Study Start Date: November 2001
Estimated Study Completion Date: December 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00028405

Locations
United States, Arizona
University of Arizona, VA Medical Center
Tucson, Arizona, United States, 85723
United States, Michigan
Detroit Medical Center, Wayne State University
Detroit, Michigan, United States, 48201
United States, North Carolina
East Carolina State University, Brody School of Medicine
Greenville, North Carolina, United States, 27858
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Light Sciences LLC
Investigators
Study Director: Jay Winship, MD Sr. Vice President of R & D and Chief Medical Officer
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00028405     History of Changes
Obsolete Identifiers: NCT00049205
Other Study ID Numbers: LSC-OL001
Study First Received: January 4, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Light Sciences LLC:
Photodynamic Therapy
Bulky Tumor
Refractory Tumor
Head and Neck Cancer
Breast Cancer
Pelvic Tumors
Liver Metastasis
Colorectal Cancer
Sarcoma
Anal Cancer
Oral Cancer
Recurrent
Lymphadenopathy
Ovarian Cancer
Cervical Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Head and Neck Neoplasms
Mouth Neoplasms
Neoplasm Metastasis
Sarcoma
Breast Diseases
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Mouth Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue
Neoplastic Processes
Pathologic Processes
Rectal Diseases
Skin Diseases
Stomatognathic Diseases
Talaporfin
Antineoplastic Agents
Dermatologic Agents
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 19, 2014