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

Expanded access is currently available for this treatment.
Verified May 2016 by Provectus Pharmaceuticals
Information provided by (Responsible Party):
Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
First received: December 13, 2010
Last updated: May 9, 2016
Last verified: May 2016
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.

Condition Intervention
Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory
Approved Alternative Therapy
Drug: PV-10 (10% rose bengal disodium)

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Provectus Pharmaceuticals:

Intervention Details:
    Drug: PV-10 (10% rose bengal disodium)
    Intralesional injection for chemoablation of cutaneous or subcutaneous lesions

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260779

Contact: Eric Wachter wachter@pvct.com

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Contact: Mary Healey    502-629-3327    Mary.Healey@louisville.edu   
Principal Investigator: Charles Scoggins, M.D.         
United States, Pennsylvania
St Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Contact: Rose Cabral, RN    484-503-4151    Rosemarie.Cabral@sluhn.org   
Principal Investigator: Sanjiv Agarwala, M.D.         
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77230
Contact: Donna Branham    713-563-3527    dbranham@mdanderson.org   
Principal Investigator: Merrick I Ross, M.D.         
Australia, New South Wales
Melanoma Institute Australia
Sydney (North Sydney and Camperdown), New South Wales, Australia
Contact: Georgia Cairns    +61 (02) 9911 7269    Georgia.Cairns@melanoma.org.au   
Contact: Natalie Foster    +61 (02) 9515 5578    Natalie.Foster@melanoma.org.au   
Principal Investigator: John F Thompson, M.D.         
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Contact: Janine Thomas    +61 (07) 3844 8500    Janine.thomas@mater.uq.edu.au   
Principal Investigator: Mark Smithers, M.D.         
Australia, South Australia
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, Australia
Contact: Caroline Rawling    +61 (08) 8222 4765    Caroline.Rawling@health.sa.gov.au   
Principal Investigator: Susan Neuhaus, M.D.         
Sponsors and Collaborators
Provectus Biopharmaceuticals, Inc.
  More Information

Responsible Party: Provectus Biopharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01260779     History of Changes
Other Study ID Numbers: PV-10-EA-02 
Study First Received: December 13, 2010
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on May 26, 2016