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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
Be older than 18 years old
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

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
~5 spots leftby Jun 2025
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