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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260779
Expanded Access Status : No longer available
First Posted : December 15, 2010
Last Update Posted : July 11, 2016
Information provided by (Responsible Party):
Provectus Pharmaceuticals ( Provectus Biopharmaceuticals, Inc. )

Brief Summary:
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 or disease Intervention/treatment
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
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 the National Library of Medicine

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260779

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

Responsible Party: Provectus Biopharmaceuticals, Inc. Identifier: NCT01260779     History of Changes
Other Study ID Numbers: PV-10-EA-02
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016