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

Expanded access is currently available for this treatment.
Verified June 2014 by Provectus Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Provectus Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01260779
First received: December 13, 2010
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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
  Eligibility

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

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

Contacts
Contact: Eric Wachter wachter@pvct.com

Locations
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
Contact: Lisa Obregon, RN, BSN, OCN    858-939-5052    Lisa.Obregon@sharp.com   
Principal Investigator: Paul M. Goldfarb, M.D.         
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Contact: Randi K Eden, BA, CCRP    502-629-3384    rkeden01@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: Sheila Taylor, RN    713-563-0953    shataylor@mdanderson.org   
Principal Investigator: Merrick I Ross, M.D.         
Australia, New South Wales
Melanoma Institute Australia
North Sydney, New South Wales, Australia, 2060
Contact: Therese Olsson    +61 (02) 9911 7302    Therese.olsson@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    janine1972@hotmail.com   
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 Pharmaceuticals
  More Information

No publications provided

Responsible Party: Provectus Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01260779     History of Changes
Other Study ID Numbers: PV-10-EA-02
Study First Received: December 13, 2010
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on October 21, 2014