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

Provectus Biopharmaceuticals

Status

Conditions: Approved Alternative Therapy; Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory

Treatments: Drug: PV-10 (10% rose bengal disodium)

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT01260779

PV-10-EA-02

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.