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NCT03370406 · ClinicalTrials.gov registry record · Phase 1
Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC
A Phase 1 study of Carcinoma, Squamous Cell, sponsored by Melissa Pugliano-Mauro.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03370406: Recruiting Phase 1 study of Carcinoma, Squamous Cell, sponsored by Melissa Pugliano-Mauro.
NCT03370406 is a Phase 1 study of Carcinoma, Squamous Cell that is actively recruiting participants, run by Melissa Pugliano-Mauro. The registered enrollment target is 30 participants, below the 258-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03370406, a Phase 1 study of Carcinoma, Squamous Cell, is actively recruiting participants, sponsored by Melissa Pugliano-Mauro.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To assess Dose Limiting Toxicities (DLT) of intralesional-5FU and intralesional 5FU combined with topical imiquimod in subjects after 3 weeks of treatment. Dose Limiting Toxicities (DLT) are defined as: Higher-than grade 2 hematologic or non-hematologic toxicity that is definitely, probably, or possibly related to intralesional 5FU administration and/or topical imiquimod application. The NCI common terminology criteria for adverse events (CTCAE) version 4.0 will be used. Based on the results
Conditions Studied
Interventions
- DRUG 5-fluorouracil
- DRUG Calcipotriene
Study Locations (1)
Pennsylvania
- St. Margaret Hospital Dermatology - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-08-03 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
What NCT03370406 shows while recruiting
NCT03370406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 258-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Carcinoma, Squamous Cell appearing as the primary indexed condition, and to 2 interventions - of which 5-fluorouracil is the first listed.
NCT03370406 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03370406 about?
NCT03370406 is a clinical study titled "Intralesional 5-Fluorouracil (5FU), Topical Calcipotriene Treatment for SCC". 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 intralesio...
What is the current status of trial NCT03370406?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-08-03. Estimated completion is 2026-10-30.
What conditions does trial NCT03370406 study?
This clinical trial studies the following conditions: Carcinoma, Squamous Cell.
What interventions are being tested in trial NCT03370406?
The interventions under investigation include: 5-fluorouracil (DRUG), Calcipotriene (DRUG).
Who is sponsoring clinical trial NCT03370406?
This trial is sponsored by Melissa Pugliano-Mauro, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03370406 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03370406's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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