Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors
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
1 other identifier
expanded_access
N/A
2 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedJuly 11, 2016
July 1, 2016
December 13, 2010
July 8, 2016
Conditions
Interventions
Intralesional injection for chemoablation of cutaneous or subcutaneous lesions
Eligibility Criteria
You may qualify if:
- 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 0-2.
- Life Expectancy: At least 6 months.
- 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).
- Thyroid Function
- Total T3 or free T3 (serum triiodothyronine), total T4 or free T4 (serum thyroxine) and THS (serum thyrotropin) ≤ grade 2 abnormality.
- Renal Function
- Subjects must have adequate renal function in the opinion of the Investigator with no clinically significant renal impairment or uncontrolled renal disease.
You may not qualify if:
- 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.
- 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.
- Investigational Agents:
- Subjects who have received investigational agents within 4 weeks (or 5 half-lives) of study administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Louisville
Louisville, Kentucky, 40202, United States
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
MD Anderson Cancer Center
Houston, Texas, 77230, United States
Melanoma Institute Australia
Sydney (North Sydney and Camperdown), New South Wales, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, Australia