Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03370406
The ClinicalTrials.gov registry entry for NCT03370406 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 258-participant average among 14 other Carcinoma, Squamous Cell trials with a reported enrollment target (88% lower). The listed sponsor is Melissa Pugliano-Mauro, which has 3 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Carcinoma, Squamous Cell
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC
RECRUITING · Phase 1
-
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
RECRUITING · Phase 1
-
Study of MEDI0562 Prior to Surgical Resection in Head and Neck Squamous Cell Carcinoma (HNSCC) or Melanoma
ACTIVE NOT RECRUITING · Phase 1
-
A Phase I/II Study of Radiation Therapy, Paclitaxel Poliglumex and Cetuximab in Advanced Head and Neck Cancer
COMPLETED · Phase 1
-
Prospective Observational Study to Validate Circulating HPVDNA and Prognostic Genomic Biomarkers in HPV-associated OPSCC
RECRUITING
-
Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment
RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.