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| Sponsor: | Light Sciences LLC |
|---|---|
| Information provided by: | Light Sciences LLC |
| ClinicalTrials.gov Identifier: | NCT00028405 |
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 I |
| 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 |
| Estimated Enrollment: | 48 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | December 2002 |
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 |
Primary Inclusion Criteria:
All tumors must:
Exclusion Criteria:
Contacts and 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 | |
| Study Director: | Jay Winship, MD | Sr. Vice President of R & D and Chief Medical Officer |
More Information
| 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 |
|
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 |
|
Breast Neoplasms Rectal Neoplasms Colorectal Neoplasms Head and Neck Neoplasms Mouth Neoplasms Neoplasm Metastasis Liver Neoplasms Pelvic Neoplasms Sarcoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Mouth Diseases Stomatognathic Diseases Neoplastic Processes Pathologic Processes Liver Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Talaporfin Antineoplastic Agents |