Photodynamic Therapy System for Patients With Refractory/Unresponsive Solid Tumors
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
1 other identifier
interventional
48
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2001
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
January 4, 2002
CompletedFirst Posted
Study publicly available on registry
January 9, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2002
CompletedJune 24, 2005
March 1, 2003
January 4, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Arizona, VA Medical Center
Tucson, Arizona, 85723, United States
Detroit Medical Center, Wayne State University
Detroit, Michigan, 48201, United States
East Carolina State University, Brody School of Medicine
Greenville, North Carolina, 27858, United States
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Related Publications (1)
Taber SW, Fingar VH, Coots CT, Wieman TJ. Photodynamic therapy using mono-L-aspartyl chlorin e6 (Npe6) for the treatment of cutaneous disease: a Phase I clinical study. Clin Cancer Res. 1998 Nov;4(11):2741-6.
PMID: 9829737BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jay Winship, MD
Sr. Vice President of R & D and Chief Medical Officer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2002
First Posted
January 9, 2002
Study Start
November 1, 2001
Study Completion
December 1, 2002
Last Updated
June 24, 2005
Record last verified: 2003-03