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Virus Therapy

PV-10 (10% rose bengal disodium) for Liver Cancer

Phase 1
Waitlist Available
Research Sponsored by Provectus Biopharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older, males and females.
Histologically or cytologically confirmed, or clinically diagnosed based on currently accepted standards, cancer metastatic to the liver or HCC that is not amenable at the time of enrollment to resection, transplant or other potentially curative therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for up to 100 months
Awards & highlights

Study Summary

This trial will test a new cancer drug, PV-10, given as a single injection. It will measure safety, how well the body tolerates it, and how it affects tumor growth in people with liver cancer that cannot be removed by surgery.

Eligible Conditions
  • Liver Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
  • Uveal Melanoma
  • Breast Cancer
  • Lung Cancer
  • Colon Cancer
  • Melanoma
  • Ocular Melanoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for up to 100 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for up to 100 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of hepatic administration of PV-10
Secondary outcome measures
Changes in markers of hepatic function
Objective response rate (ORR)
Overall survival
+2 more
Other outcome measures
Exploratory Correlative Endpoints

Side effects data

From 2012 Phase 2 trial • 80 Patients • NCT00521053
81%
Injection site pain
40%
Injection site oedema
38%
Injection site vesicles
31%
Injection site discolouration
25%
Injection site swelling
21%
Injection site pruritus
21%
Nausea
18%
Headache
14%
Injection site erythema
13%
Constipation
10%
Diarrhoea
9%
Vomiting
9%
Arthralgia
8%
Injection site photosensitivity reaction
8%
Injection site inflammation
8%
Nasopharyngitis
6%
Injection site infection
6%
Fatigue
6%
Oedema peripheral
6%
Decreased appetite
6%
Musculoskeletal pain
5%
Injection site ulcer
5%
Injection site cellulitis
5%
Injection site rash
5%
Abdominal pain
5%
Injection site warmth
5%
Lethargy
5%
Back pain
3%
Pneumonia
1%
Injection site necrosis
1%
Pituitary disorder
1%
Photosensitivity reaction
1%
Dysphagia
1%
Atrial fibrillation
1%
Back injury
1%
Delayed recovery from anaesthesia
1%
Left ventricular hypertrophy
1%
Cholecystitis
1%
Pyrexia
1%
Viral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
PV-10

Trial Design

1Treatment groups
Experimental Treatment
Group I: PV-10 Injection (Intralesional)Experimental Treatment1 Intervention
Subjects in each of three cohorts will receive a single dose of PV-10 to one Target Lesion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PV-10 (10% rose bengal disodium)
2007
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

Provectus Biopharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
Eric Wachter, PhDStudy DirectorProvectus Biopharmaceuticals, Inc.
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations involving PV-10 (10% rose bengal disodium) have been conducted?

"Currently, 3 clinical trials are underway which involve PV-10 (10% rose bengal disodium), 1 of which is in the last phase. Most of these projects are located around Tampa, Florida; however there are 15 other sites conducting research with this drug."

Answered by AI

How many participants are the maximum capacity of this research endeavor?

"This clinical trial is no longer in the process of enrolling participants, having first been posted on October 1st 2009. However, individuals with pancreatic metastatic cancer still have 3,616 active studies they can explore while those interested in PV-10 (10% rose bengal disodium) can look into three existing trials still accepting recruits."

Answered by AI

Are there any vacancies for participants in this clinical investigation?

"Regrettably, this trial has concluded its recruitment period. It was posted on October 1st 2009 and last amended on the 31st of October in 2022. However, for those searching for other studies currently enrolling patients with pancreatic metastatic cancer, there are 3616 trials available; likewise, 3 clinical studies related to 10% rose bengal disodium (PV-10) remain active at present."

Answered by AI

Has this experimental research ever been attempted before?

"Currently, there are 3 ongoing clinical trials for PV-10 (10% rose bengal disodium) scattered throughout 13 cities and 3 countries. Provectus Biopharmaceuticals, Inc., pioneered the first Phase 1 study of this drug in 2009 with 78 participants; since then 5 more studies have been conducted."

Answered by AI

Does PV-10 (10% rose bengal disodium) present any significant risk to patients?

"PV-10 (10% rose bengal disodium) has only undergone preliminary testing, so it scored a 1 on our team's safety assessment scale."

Answered by AI
~5 spots leftby Mar 2025