Clinical Trial: Effectiveness of Imiquimod Topical Cream in Early Stage Cutaneous T-cell Lymphoma

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Feasibility Study to Determine Effectiveness of 3.75% Topical Imiquimod Cream and Topical Vanos (Fluocinonide) Cream 0.1% in the Treatment of Early Stage Cutaneous T-cell Lymphoma

Brief Summary: This study is being conducted by Brian Poligone, MD PhD. The purpose of this study is to determine safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage Cutaneous T-cell Lymphoma (CTCL).

Detailed Summary: The purpose of the study is to compare the safety, effectiveness, and tolerability of two topical therapies, imiquimod and fluocinonide, for patients with early stage CTCL.
Sponsor: Rochester General Hospital

Current Primary Outcome: Response Rate between baseline and week 16 [ Time Frame: 16 weeks ]

Treatment phase will last 4 months with follow up at 6 and 12 months after initiation of therapy


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Response Rate 24 and 52 weeks after baseline [ Time Frame: Baseline to up to one year ]
    Patients will be treated for 4 months and response rate assessed at 6 and 24 months after initiation of therapy.
  • Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events) [ Time Frame: From Randomization to up to 30 days after end of treatment ]
    We will record any adverse events that occur during the course of the study.
  • Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies) [ Time Frame: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16) ]
    Using left over tissue from biopsies done at baseline, two weeks after initiation of therapy, and optional one done at week16. We are interested in making our tissue bank.


Original Secondary Outcome:

  • Response Rate 24 and 52 weeks after baseline [ Time Frame: Baseline to up to one year ]
    Patients will be treated for 4 months and response rate assessed at 6 and 24 months after initiation of therapy.
  • Change (%) in Physician Global Assessment between baseline and week 16 [ Time Frame: 16 weeks from baseline ]
  • Safety and tolerabiliy of Imiquimod in patients with CTCL (adverse events) [ Time Frame: From Randomization to up to 30 days after end of treatment ]
    We will record any adverse events that occur during the course of the study.
  • Learn about T cell dysregulation in the skin from patients with CTCL (Using left over tissue from biopsies) [ Time Frame: Samples may be stored indefinitely from time of collection ( two weeks after initiation of therapy, and optional one done at week16) ]
    Using left over tissue from biopsies done at baseline, two weeks after initiation of therapy, and optional one done at week16. We are interested in making our tissue bank.


Information By: Rochester General Hospital

Dates:
Date Received: November 19, 2014
Date Started: June 2017
Date Completion: June 2018
Last Updated: March 28, 2017
Last Verified: March 2017