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

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

• Registration Number: NCT01260779
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-15
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-08
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: NO_LONGER_AVAILABLE
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: EXPANDED_ACCESS
• Study Design: Not specified

Trial Locations

Locations (6)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Royal Adelaide Hospital Cancer Centre; 🇦🇺 Adelaide, South Australia, Australia

St Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States

Melanoma Institute Australia; 🇦🇺 Sydney (North Sydney and Camperdown), New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Brisbane, Queensland, Australia

University of Louisville; 🇺🇸 Louisville, Kentucky, United States