Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028405
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-01-04
Brief Title:
Photodynamic Therapy System for Patients With RefractoryUnresponsive Solid Tumors
Sponsor:
Light Sciences LLC
Organization:
Light Sciences LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multi-center photodynamic therapy study plans to treat patients with large tumors in any superficial location sarcoma tumors of oraloro-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None