Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00028405|
Recruitment Status : Completed
First Posted : January 9, 2002
Last Update Posted : June 24, 2005
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|Condition or disease||Intervention/treatment||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 (Clinical Trial)|
|Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2001|
|Study Completion Date :||December 2002|
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00028405
|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|
|University of Pennsylvania School of Medicine|
|Philadelphia, Pennsylvania, United States, 19104|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|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|
|Other Study ID Numbers:||
|First Posted:||January 9, 2002 Key Record Dates|
|Last Update Posted:||June 24, 2005|
|Last Verified:||March 2003|
Head and Neck Cancer
Head and Neck Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type