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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Melissa Pugliano-Mauro
Study ID
NCT03370406
Phase
PHASE1
Status
Recruiting
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Conditions

  • Carcinoma, Squamous Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 5-fluorouracil — DRUG
    Intralesional injections of 50mg/ml over a 3 week period.
  • Calcipotriene — DRUG
    Topical application of .005% cream two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections..

Study Details

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.

Key Dates

Start date
Aug 3, 2018
Status verified
May 2026
Primary completion
Sep 30, 2027
Completion
Oct 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control Group
    Control group will receive neither 5-fluorouracil (5FU) injection nor topical 0.005% calcipotriene cream. This group will receive standard of care only. Lesion will be surgical resected on day 84 of study.
  • Experimental: 5FU Group
    5-fluorouracil (5FU) Group participants will receive a 1ml intralesional injection of 5FU 50mg/ml aqueous injectable solution. One injection will be administered once monthly for 3 month. Injections will occur on d0, d28, and d56. On the 4th visit the lesion site will be locally anesthetized and a 4mm punch biopsy will be taken to confirm pathologic resolution. Depending on the results of the confirmational biopsy the following actions will be taken: 1. Negative biopsy - clinical follow-up every 6 months for 2 years 2. Positive biopsy - Mohs surgery 2-4 weeks after
  • Experimental: 5FU + 0.005% Calcipotriene cream Group
    5-fluorouracil (5FU) + 0.005% calcipotriene cream Group participants will receive intralesional 5FU as in the previous group, additionally participants will also receive two (2) times daily for four (4) days one (1) day after each of three (3) 5FU injections topical application of 0.005% calcipotriene cream to the same lesion. On the 4th visit the lesion site will be locally anesthetized and a 4mm punch biopsy will be taken to confirm pathologic resolution. Depending on the results of the confirmational biopsy the following actions will be taken: 1. Negative biopsy - clinical follow-up every 6 months for 2 years 2. Positive biopsy - Mohs surgery 2-4 weeks after

Primary Outcome Measure

Determine number of subjects experiencing Dose Limiting Toxicity (DLT) higher than grade 2, as defined by CTCAE v. 4.0 [ Time Frame: 84 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Margaret Hospital DermatologyPittsburghPennsylvania15238
Melissa Pugliano-Mauro, MD
[email protected]
412-784-7350
Jeff Plowey, MS, MBA
[email protected]
412-784-7350
Melissa Pugliano-Mauro, MD (PRINCIPAL_INVESTIGATOR)
Kevin Savage, MD (SUB_INVESTIGATOR)
Hannah Glass, PA-C (SUB_INVESTIGATOR)
Jeff Plowey, MS, MBA (SUB_INVESTIGATOR)

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By research site
St. Margaret Hospital Dermatology· Pittsburgh, PA

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