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Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors Clinical research trials and Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors. Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors  Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
For Condition: Sarcoma,Rectal Cancer,Mouth Cancer,Breast Cancer,Head and Neck Cancer,Pelvic Cancer,Liver Metastasis,Colorectal Cancer
Status: Completed
Sponsor(s): Light Sciences Corporation ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 48
Location and Contact Information:
Overall Study Official:
JayWinship, Study Director, Sr. Vice President of R & D and Chief Medical Officer
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
United States
University of Arizona, VA Medical Center
Tucson, Arizona, 85723
United States
Detroit Medical Center, Wayne State University
Detroit, Michigan, 48201
United States
Virginia Mason Medical Center
Seattle, Washington, 98101
United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States
East Carolina State University, Brody School of Medicine
Greenville, North Carolina, 27858
United States
Additional Information:
Study ID Numbers: LSC-OL001;
Study Start Date: November 2001
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00028405
Other Pelvic Cancer Studies:
1. A Two Stage Study of the Safety and Efficacy of Bay 43-9006 in Colorectal Cancer and Other Cancers
2. Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
3. A Study of ABT-751 in Patients With Colorectal Cancer
4. A Trial of ALIMTA (pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.
5. The identification of prognostic factors of late stage disease, particularly those that are modifiable, that might explain the worsened prognosis with colorectal cancer among veterans.
Related Studies:
Other Pelvic Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Greenville Clinical Trials
Photodynamic Therapy System for Patients with Refractory/Unresponsive Solid Tumors
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