A Phase I/II 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, 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy
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.
6 months
No
Randall F Holcombe, MD
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
108643
NCT01522677
January 2012
December 2013
Name | Location |
---|---|
University of California, Irvine | Orange, California 92868 |
Mounst Sinai School of Medicine | New York, New York 10029 |