Cutaneous or Subcutaneous Tumors Where There is no Comparable or SatisfactoryNCT01260779
Expanded Access Protocol for PV-10 for Cutaneous or Subcutaneous Tumors
A study testing PV-10 (10% rose bengal disodium) in people with Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory and Approved Alternative Therapy, run by Provectus Biopharmaceuticals, Inc. at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory, Approved Alternative Therapy
- What is being tested?
- PV-10 (10% rose bengal disodium)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 6 sitesin 2 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015
MD Anderson Cancer Center
Houston, Texas, 77230
University of Louisville
Louisville, Kentucky, 40202
Australia3 sites
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Melanoma Institute Australia
Sydney (North Sydney and Camperdown), New South Wales
About this study
Official title: 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.
- Conditions
- Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory, Approved Alternative Therapy
- Being tested
- PV-10 (10% rose bengal disodium)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PV-10 (10% rose bengal disodium)Drug
Intralesional injection for chemoablation of cutaneous or subcutaneous lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous or Subcutaneous Tumors Where There is no Comparable or SatisfactoryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260779
- Sponsor's protocol ID
- PV-10-EA-02
- Status last verified
- Jul 2016
- First submitted
- 13 Dec 2010
- Last updated
- 11 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01260779
- Acronym / sponsor ID
- PV-10-EA-02
- Conditions
- Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory, Approved Alternative Therapy
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Provectus Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 15 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (14 listed)
- 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:
- Pregnancy:
- Investigational Agents:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PV-10 (10% rose bengal disodium)Intralesional injection for chemoablation of cutaneous or subcutaneous lesions | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PV-10 (10% rose bengal disodium) in people with Cutaneous or Subcutaneous Tumors Where There is no Comparable or Satisfactory and Approved Alternative Therapy, run by Provectus Biopharmaceuticals, Inc. at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.