A Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer
The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers by colonoscopy to induce localized inflammatory/immune response. The objective is to demonstrate the feasibility and safety of PDT to colon cancer patients administered before surgery and to characterize the inflammatory/immune response at the tumor site and systemically. The long-term objective of these studies is to modify he natural biology of colorectal cancers and improve patient survival.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer|
- Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]Define biologic efficacy of PDT in relation to generation of an immune response at the tumor site and systemically. This will be measured by degree of dendritic cell infiltration into tumor and regional lymph nodes, and degree of systemic immunity directed against colon cancer antigens immedicately post procedure and after 6 months.
- Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Safety will be evaluated from enrollment through 6 months. This will be measured by proportion of patients completing planned surgery, proportion of patients experiencing grade 3 or 4 toxicities, and lack of observation of serious adverse events related to the study procedure.
- Quality of Life [ Time Frame: 6 months after completion of participation ] [ Designated as safety issue: No ]Quality of life will be evaluated 6 months following completion of participation in the study
- Sustained immunity [ Time Frame: 1.5-6 months post completion of participation ] [ Designated as safety issue: No ]Immunologic parameters will be monitored following completion of the study as a measure of sustained immunity
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Participants receive neoadjuvant 5-ALA and PDT.
Drug: PDT with 5-ALA radiosensitization
Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.
The central hypothesis for this study is that it is safe and feasible to administer intraluminal photodynamic therapy (PDT) to colon cancers, via colonoscopy, in the neoadjuvant setting to induce localized tumor cell death and an inflammatory/immune response with an increased Th1 component, utilizing 5-ALA as a photosensitizer. The objective is to conduct an initial phase I/II clinical study to demonstrate the feasibility and safety of colonoscopic, neoadjuvant intraluminal PDT to colon cancer patients administered 96 hours pre-resection, to characterize the inflammatory/immune response at the PDT treated tumor site, and to evaluate the systemic anti-tumor immune response. The long-term objective of these studies is to provide an easily administered, adjunctive, therapeutic maneuver that lacks systemic toxicity, with the potential to modulate the natural biology of colorectal cancers that have not elicited a favorable anti-tumor immune response and to improve patient survival.
|Contact: Randall F Holcombe, MDemail@example.com|
|Contact: Edward L Nelson, MDfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine||Recruiting|
|Orange, California, United States, 92868|
|Contact: Edward L Nelson, MD 714-456-5153 email@example.com|
|Principal Investigator: Edward L Nelson, MD|
|United States, New York|
|Mounst Sinai School of Medicine||Recruiting|
|New York, New York, United States, 10029|
|Contact: Randall F Holcombe, MD 212-659-5420 firstname.lastname@example.org|
|Contact: Kiev Gimpel-Tetra, RN 2128247117 email@example.com|
|Principal Investigator: Randall F Holcombe, MD|
|Principal Investigator:||Randall F Holcombe, MD||Mount Sinai School of Medicine|
|Principal Investigator:||Edward L Nelson, MD||University of California, Irvine|