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Detection of Immune Cell Infiltration Into Melanomas Treated by PV-10, a Feasibility Study

NCT01760499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-04-19

No results posted yet for this 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.

Conditions

Interventions

DRUG

PV-10

PV-10 administration: Within one week after completing the screening tests (or the same day as the screening tests), participants will be scheduled to have the study drug (PV-10) administered. PV-10 is given as an injection with a needle, directly into one of the participant's tumors. Participants will be given an injection of a numbing medication before the PV-10 is given.

PROCEDURE

Surgery

Surgery to remove melanoma tumors (Day 7-14): About 7-14 days after the PV-10 is given, participants will have surgery to remove their melanoma tumors. A piece of the tumor that was injected with PV-10 along with a piece of one other tumor will be sent to the laboratory for testing as part of the study.

Sponsors & Collaborators

  • Provectus Pharmaceuticals

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Amod A. Sarnaik, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-24
Primary Completion
2015-12-29
Completion
2017-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760499 on ClinicalTrials.gov