Trial record 4 of 19 for:
Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors
Expanded access is currently available for this treatment.
Verified March 2014 by Provectus Pharmaceuticals
Information provided by (Responsible Party):
First received: December 13, 2010
Last updated: March 24, 2014
Last verified: March 2014
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.
Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory
Approved Alternative Therapy
Drug: PV-10 (10% rose bengal disodium)
What is Expanded Access?
||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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
- Age 18 years or older, male or female.
- Histologically or cytologically confirmed cancer where there is no comparable or satisfactory approved alternative therapy specific to cutaneous or subcutaneous tumors.
- Performance Status: ECOG 0-3.
- Life Expectancy: At least 6 months.
- 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).
- Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and THS (serum thyrotropin) ≤ grade 2 abnormality.
- Subjects must have adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.
- Cancer patients who are eligible for an existing PV-10 clinical trial.
- Certain photosensitizing agents within 5 half-lives prior to PV-10 administration.
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.
- 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.
- Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of study administration.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260779
|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. |
|University of Louisville
|Louisville, Kentucky, United States, 40202 |
|Contact: Randi K Eden, BA, CCRP 502-629-3384 email@example.com |
|Principal Investigator: Charles Scoggins, M.D. |
|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. |
|Melanoma Institute Australia
|North Sydney, New South Wales, Australia, 2060 |
|Contact: Therese Olsson +61 (02) 9911 7302 Therese.firstname.lastname@example.org |
|Principal Investigator: John F Thompson, M.D. |
|Princess Alexandra Hospital
|Brisbane, Queensland, Australia, 4102 |
|Contact: Janine Thomas +61 (07) 3844 8500 email@example.com |
|Principal Investigator: Mark Smithers, M.D. |
|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. |
No publications provided
ClinicalTrials.gov processed this record on April 17, 2014
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 13, 2010
||March 24, 2014
||United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration