Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors

Open Label Expanded Access for Investigational Use of PV-10 in Patients Who Are Not Eligible for an Existing PV-10 Clinical Trial, for Whom There is no Alternative Therapy, and Whom May Benefit From PV-10 Administration

This compassionate use protocol provides expanded access for investigational use of PV-10 in cancer patients who are not eligible for an existing PV-10 clinical trial, for whom there is no comparable or satisfactory approved alternative therapy and whom, in the opinion of the investigator, may benefit from PV-10 administration.

Study Overview

• Status: No longer available
• Conditions: Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory; Approved Alternative Therapy
• Intervention / Treatment: Drug: PV-10 (10% rose bengal disodium)

• Study Type: Expanded Access

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney (North Sydney and Camperdown), New South Wales, Australia
      • Melanoma Institute Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Royal Adelaide Hospital Cancer Centre
• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St Luke's University Health Network
  • Texas
    • Houston, Texas, United States, 77230
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or older, male or female.
2. Histologically or cytologically confirmed cancer where there is no comparable or satisfactory approved alternative therapy specific to cutaneous or subcutaneous tumors.
3. Performance Status: ECOG 0-2.
4. Life Expectancy: At least 6 months.

5. Blood Chemistry:

   • Creatinine ≤ 3 times the upper limit of normal (ULN).
   • Total bilirubin ≤ 3 times the upper limit of normal (ULN).
   • AST/ALT/ALP ≤ 5 times the upper limit of normal (ULN).

6. Thyroid Function

   • Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and THS (serum thyrotropin) ≤ grade 2 abnormality.

7. Renal Function

   • Subjects must have adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.

Exclusion Criteria:

1. Cancer patients who are eligible for an existing PV-10 clinical trial.
2. Certain photosensitizing agents within 5 half-lives prior to PV-10 administration.

3. Concurrent or Intercurrent Illness:

   • Subjects with uncontrolled diabetes or extremity complications due to diabetes.
   • Subjects with severe peripheral vascular disease.
   • Subjects with significant concurrent or intercurrent illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the Investigator, compromise their safety or compliance or interfere with interpretation of study results.
   • Subjects with uncontrolled thyroid disease, goiter, partial thyroidectomy, radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis.
   • Subjects with clinically significant acute or unstable cardiovascular, (stroke), renal, gastrointestinal, pulmonary, immunological (with the exception of the presence of hepatitis B virus (HBV), viral hepatitis, or cirrhosis), endocrine, or central nervous system disorders.

4. Pregnancy:

   • Female subjects who are pregnant or lactating.
   • Female subjects who have positive serum ßHCG pregnancy test taken within 7 days of PV-10 administration.
   • Fertile subjects who are not using effective contraception.

5. Investigational Agents:

   • Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of study administration.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Provectus Biopharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 15, 2010

Study Record Updates

• Last Update Posted (Estimate): July 11, 2016
• Last Update Submitted That Met QC Criteria: July 8, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PV-10-EA-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No