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NCT01760499 · ClinicalTrials.gov registry record · Phase 1
Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01760499: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01760499 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01760499, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The main purpose of this study is to find out more about how PV-10 works in melanoma tumors. Researchers also want to find out if there are changes in the body's immune cells (cells that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and circulating in the blood.
Primary Outcome
The pre-treatment blood sample and tumor biopsies will be the control for the post-PV-10 blood samples and resected tumor samples. Tumor core needle biopsies will be collected from the designated injected and uninjected lesions one week prior to intralesional PV-10 therapy. Biopsy samples will be fixed in formalin and embedded in paraffin for immunohistochemical (IHC) staining. On day 0, the injected lesion will be treated with up to 5 mL of PV-10. Seven to 14 days after intralesional PV-10 trea
Interventions
- PROCEDURE Surgery
- DRUG PV-10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2013-01-24 |
| Est. Completion | 2017-04 |
| Phase | Phase 1 |
What the finished NCT01760499 record still lists
NCT01760499 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Surgery is the first listed.
NCT01760499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01760499 about?
NCT01760499 is a clinical study titled "Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study". The main purpose of this study is to find out more about how PV-10 works in melanoma tumors. Researchers also want to find out if there are changes in the body's immune cells (cells that fight infection and illnesses) after PV-10 is given, both inside the melanoma tumors and circulating in the blood...
What is the current status of trial NCT01760499?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2013-01-24. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01760499?
The interventions under investigation include: Surgery (PROCEDURE), PV-10 (DRUG).
Who is sponsoring clinical trial NCT01760499?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01760499's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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