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
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.
Primary
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Jay Winship, MD
Study Director
Sr. Vice President of R & D and Chief Medical Officer
United States: Food and Drug Administration
LSC-OL001
NCT00028405
November 2001
December 2002
Name | Location |
---|---|
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Arizona, VA Medical Center | Tucson, Arizona 85723 |
Detroit Medical Center, Wayne State University | Detroit, Michigan 48201 |
East Carolina State University, Brody School of Medicine | Greenville, North Carolina 27858 |
Albert Einstein Medical Center | Philadelphia, Pennsylvania 19141 |
University of Pennsylvania School of Medicine | Philadelphia, Pennsylvania 19104 |