Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC

Summary

This clinical trial proposes to evaluate a relatively unexplored approach to treatment of squamous cell carcinoma (SCC) on the lower extremities. The strategy is to directly and specifically deliver drug to the tumor. For the proposed phase I clinical trial, the investigators will perform intralesional injections of a well characterized, potent chemotherapeutic agent 5-fluorouracil (5FU) with and without a topical application of 0.005% calcipotriene cream to kill topically accessible SCC cells. The goal of the study is to evaluate the safety profile and tolerability of intralesional-5FU with and without a concomitant topical calcipotriene and measure the clinical objective response rate (ORR) in treated lesions compared to untreated lesions 3 weeks after treatment.

Timeline

Start

2018-08-03

Primary completion

2027-09-30

Completion

2027-10-30

Publications

• Background Rosenberg AR, Tabacchi M, Ngo KH, Wallendorf M, Rosman IS, Cornelius LA, Demehri S. Skin cancer precursor immunotherapy for squamous cell carcinoma prevention. JCI Insight. 2019 Mar 21;4(6):e125476. doi: 10.1172/jci.insight.125476. eCollection 2019 Mar 21.
• Background Cunningham TJ, Tabacchi M, Eliane JP, Tuchayi SM, Manivasagam S, Mirzaalian H, Turkoz A, Kopan R, Schaffer A, Saavedra AP, Wallendorf M, Cornelius LA, Demehri S. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest. 2017 Jan 3;127(1):106-116. doi: 10.1172/JCI89820. Epub 2016 Nov 21.
• Background Kim C, Ko CJ, Leffell DJ. Cutaneous squamous cell carcinomas of the lower extremity: a distinct subset of squamous cell carcinomas. J Am Acad Dermatol. 2014 Jan;70(1):70-4. doi: 10.1016/j.jaad.2013.09.026. Epub 2013 Nov 5.
• Background Solus JF, Murphy GF, Kraft S. Cutaneous Squamous Cell Carcinomas of the Lower Extremities Show Distinct Clinical and Pathologic Features. Int J Surg Pathol. 2016 Feb;24(1):29-36. doi: 10.1177/1066896915599058. Epub 2015 Aug 10.
• Background Munday WR, Leffell DJ, McNiff JM, Ko CJ. Histopathologic features of multiple cutaneous squamous cell carcinomas of the lower extremity. J Cutan Pathol. 2016 Sep;43(9):759-65. doi: 10.1111/cup.12738. Epub 2016 Jun 14.
• Background Bangash SJ, Green WH, Dolson DJ, Cognetta AB Jr. Eruptive postoperative squamous cell carcinomas exhibiting a pathergy-like reaction around surgical wound sites. J Am Acad Dermatol. 2009 Nov;61(5):892-7. doi: 10.1016/j.jaad.2009.01.037. Epub 2009 Sep 18.
• Background Moore AY. Clinical applications for topical 5-fluorouracil in the treatment of dermatological disorders. J Dermatolog Treat. 2009;20(6):328-35. doi: 10.3109/09546630902789326.
• Background Metterle L, Nelson C, Patel N. Intralesional 5-fluorouracil (FU) as a treatment for nonmelanoma skin cancer (NMSC): A review. J Am Acad Dermatol. 2016 Mar;74(3):552-7. doi: 10.1016/j.jaad.2015.09.040. Epub 2015 Nov 11.
• Background Kraus S, Miller BH, Swinehart JM, Shavin JS, Georgouras KE, Jenner DA, Griffin E, Korey A, Orenberg EK. Intratumoral chemotherapy with fluorouracil/epinephrine injectable gel: a nonsurgical treatment of cutaneous squamous cell carcinoma. J Am Acad Dermatol. 1998 Mar;38(3):438-42. doi: 10.1016/s0190-9622(98)70502-x.
• Background Reisinger DM, Cognetta AB Jr, Pynes LT, Paredes AA Jr, Sweeney TJ, Dolson DJ. Treatment of a giant squamous cell carcinoma on the dominant thumb with intralesional 5-fluorouracil. J Am Acad Dermatol. 2011 Jul;65(1):219-21. doi: 10.1016/j.jaad.2009.11.017. No abstract available.
• Background Morse LG, Kendrick C, Hooper D, Ward H, Parry E. Treatment of squamous cell carcinoma with intralesional 5-Fluorouracil. Dermatol Surg. 2003 Nov;29(11):1150-3; discussion 1153. doi: 10.1046/j.1524-4725.2003.29355.x.
• Background Love WE, Bernhard JD, Bordeaux JS. Topical imiquimod or fluorouracil therapy for basal and squamous cell carcinoma: a systematic review. Arch Dermatol. 2009 Dec;145(12):1431-8. doi: 10.1001/archdermatol.2009.291.
• Background Peris K, Micantonio T, Fargnoli MC, Lozzi GP, Chimenti S. Imiquimod 5% cream in the treatment of Bowen's disease and invasive squamous cell carcinoma. J Am Acad Dermatol. 2006 Aug;55(2):324-7. doi: 10.1016/j.jaad.2006.04.004.

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Indications