Clinical Trial: Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Single Arm Open-Label Clinical Trial of Chemotherapy of BCC's With Tazarotene 0.1% in Subjects With Basal Cell Nevus Syndrome
Brief Summary:
RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
Detailed Summary:
OBJECTIVES:
- Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS).
- Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs.
OUTLINE: This is an open-label, multicenter study.
Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.
Sponsor: Children's Hospital & Research Center Oakland
Current Primary Outcome: Complete Response Rate [ Time Frame: 36 months ]
Original Primary Outcome: Complete Response Rate
Current Secondary Outcome:
- Time to Lesion Clearance [ Time Frame: 36 months ]
- Time to Progression [ Time Frame: 36 months ]
- Estimated Duration of Complete Response [ Time Frame: 36 months ]
- Overall Response at Treated Lesions [ Time Frame: 36 months ]
Original Secondary Outcome:
- Time to Lesion Clearance
- Time to Progression
- Estimated Duration of Complete Response
- Overall Response at Treated Lesions
Information By: Children's Hospital & Research Center Oakland
Dates:
Date Received: June 20, 2007
Date Started: July 2004
Date Completion:
Last Updated: January 13, 2016
Last Verified: January 2016