Combination 5-FU / Calcipotriene Cream for SCCIS/SCC

NCT04839731 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: IRB-19-691
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study will determine if calcipotriene and 5-fluorouracil (5-FU) creams when combined can treat SCCIS and superficially invasive SCC (but not deeply invasive or high-risk cutaneous SCC). 30 Patients will be divided into a 7 day treatment group (n=10), a 14 day treatment group (n=10), and a placebo group (n=10, divided into 7 and 14 days evenly). Following treatment with the topical chemotherapeutic medication, tumors would be completely excised according to standard of care, and specimens would be sent to pathology to determine if there was residual tumor/margin clearance. The potential benefit of this intervention would be the establishment of a non-invasive treatment that leads to minimal to no scarring or complications (akin to topical 5-FU alone) but would require a much shorter and more tolerable treatment duration (1-2 weeks) compared to available alternatives.

Conditions

Squamous Cell Carcinoma

Keywords

Calcipotriene; Fluorouracil; Squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Cancer resolution on histopathology

  Histopathologic examination of resected tumor will be examined by pathology department. If tumor cells are remaining, that will be considered positive. The number of patients with positive tumor remaining will be reported.

  6-8 wks

Secondary Outcomes (2)

• Final scar length

  6-8 wks

• Cosmetic appearance

  3-4 wks

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

10 patients will be divided into 7 and 14 day treatment groups with 5 patients each. They will apply Nourivan base cream from Pure Science Rx, twice per day for their designated time.

Drug: Nourivan Base Cream

7 day medication group

EXPERIMENTAL

The 7 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days.

Drug: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream

14 day medication group

EXPERIMENTAL

The 14 day medication group will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days.

Drug: Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream

Interventions

Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream DRUG

Apply twice per day for allotted time

14 day medication group; 7 day medication group

Nourivan Base Cream DRUG

Apply twice per day for allotted time

Placebo group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recruited patients will be limited to those with a biopsy-proven in situ or superficially invasive (does not invade past the papillary dermis) squamous cell carcinoma of the skin of the low risk or "L" areas. The tumor must measure 1.0-2.0cm in longest diameter dimension. Tumors must lack induration and/or nodularity. The tumor must also demonstrate positive margins on review of the original biopsy pathology (biopsy must be partial; there must be residual tumor that requires further treatment).
• Patient has capacity to provide consent

You may not qualify if:

• Immunocompromise or immunosuppression.
• Contraindication to surgical excision.
• Contraindication to use of topical medication(s) (e.g., history of allergic contact dermatitis to topical 5-fluorouracil)
• Currently pregant, concerned could be pregnant, actively trying to conceive, or missed last menstrual period that is not explainable by birth control method (5-Fluorouracil is pregnancy category X)
• Tumor is recurrent

Sponsors & Collaborators

• Carilion Clinic: lead

Study Sites (1)

Carilion Clinic Dermatology and Mohs Surgery

Roanoke, Virginia, 24016, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 27869649 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Mariana Phillips, MD

  Carilion Clinic Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiley K Fagan, MD

CONTACT

5402245170; kkfagan@carilionclinic.org

Mariana Phillips, MD

CONTACT

5405810170; maphillips@carilionclinic.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The three groups will include the following: Group 1 will be divided into 1- and 2-week treatment groups (5 patients in each group) and will apply placebo cream, Nourivan base cream from Pure Science Rx, twice per day for their designated time. Group 2 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 7 days, and Group 3 will apply combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream twice per day for 14 days. Patients will undergo randomization via an online randomization generator tool.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: April 9, 2021
• Study Start: April 14, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)