An Open Label Study Employing the Topical Immunomodulator Diphenylcyclopropenone in a Stabilized Gel to Treat Cutaneous Metastases
This is an open label study to determine the efficacy and mechanism(s) of the proprietary
DPCP gel composition as a topical immunotherapeutic agent for the treatment of cutaneous
metastases. This study is investigator initiated, carried out only at Rockefeller University
and the Sponsor holds the IND and is providing the test agent. The products to be evaluated
are 0.4% DPCP, in a non-volatile gel vehicle, and 0.04% DPCP in the same gel vehicle applied
to the target lesions biweekly for 14 weeks. It is our goal to apply the study drug to all
cutaneous metastatic lesions, but at the Investigator's discretion, certain lesions will be
avoided if they are in particularly difficult locations such as around the eyes or on the
lips. The estimated duration of the study is 142 days with 112 days of treatment followed by
subject examination on Day 142. If DPCP is shown to cause resolution of lesions by this
visit, there will be the possibility of continuing DPCP use as long as study medication
continues to be provided to The Rockefeller University.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
clinically evident inflammatory response elicited by DPCP
Day 142
No
James Krueger, MD
Principal Investigator
The Rockefeller University
United States: Food and Drug Administration
JKR-0788
NCT01711684
October 2012
October 2017
Name | Location |
---|---|
The Rockefeller University | New York, New York 10065 |