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

Therapuetic Areas:Oncology
Age Range:18 - Any
Contact:Eric Wachter

Use our guide to learn which trials are right for you!

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.

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

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.
We found this trial at
500 S Preston St
Louisville, Kentucky
(502) 852-5555
Principal Investigator: Charles Scoggins, M.D.
Phone: 502-629-3327
University of Louisville The University of Louisville is a state supported research university located in...
Louisville, KY
Click here to add this to my saved trials
Bethlehem, Pennsylvania
Principal Investigator: Sanjiv Agarwala, M.D.
Phone: 484-503-4151
Bethlehem, PA
Click here to add this to my saved trials
Houston, Texas 77030
Principal Investigator: Merrick I Ross, M.D.
Phone: 713-563-3527
Houston, TX
Click here to add this to my saved trials
Sydney (North Sydney and Camperdown), New South Wales 2050
Principal Investigator: John F Thompson, M.D.
Phone: +61 (02) 9911 7269
Sydney (North Sydney and Camperdown),
Click here to add this to my saved trials