MelanomaPhase 2NCT00521053
Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
A Phase 2 study testing PV-10 (10% rose bengal disodium) in people with Melanoma, run by Provectus Pharmaceuticals at 7 sites in 2 countries.
Trial summary
The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- PV-10 (10% rose bengal disodium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Sep 2007to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women, age 18 years or older.
- Histologically or cytologically confirmed metastatic melanoma, AJCC (2002) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis).
- Measurable disease in at least one lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound. Target, Non-Target and Bystander Lesions selected by discretion of Investigator.
- Performance Status: ECOG 0-2.
- Life Expectancy: At least 6 months.
- Hematopoietic:
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- White blood cell count (WBC) no less than 2500/mm3 (2.5 x 10E9/L).
- Absolute neutrophil count (ANC) no less than 1,000/mm3 (1.0 x 10E9/L).
- Platelet count no less than 90,000/mm3 (90 x 10E9/L).
- Blood Chemistry:
- Creatinine no greater than 1.5 times the upper limit of normal (ULN).
- Total bilirubin no greater than 1.5 times the upper limit of normal (ULN).
- AST/ALT no greater than 3 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) within normal limits.
- Cardiovascular Function:
- No clinically significant cardiovascular disease.
- Respiratory Function:
- No clinically significant respiratory disease.
- Immunological Function:
- No known immunodeficiency disease. Subjects must have adequate immune system function in the opinion of the Investigator.
Who cannot join
- Radiation therapy within 4 weeks of study treatment or to any Study Lesion within 12 weeks of study treatment.
- Chemotherapy:
- Chemotherapy or other systemic cancer therapy within 4 weeks of study treatment (6 weeks for nitrosoureas or mitomycin).
- Regional chemotherapy (limb infusion or perfusion) within 12 weeks of study treatment.
- Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks of study treatment.
- Investigational agents within 4 weeks (or 5 half-lives) of study treatment.
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- Photosensitizing agents within 5 half-lives of study treatment.
- Anti-tumor vaccine therapy within 6 weeks of study treatment.
- Concurrent or Intercurrent Illness:
- Severe diabetes.
- Extremity complications due to diabetes.
- 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.
- Thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, previous radioiodine- or surgically-treated Graves' hyperthyroidism or cystic fibrosis, or taking thyroid hormone medication.
- Pregnancy:
- Female subjects who are pregnant or lactating.
- Female subjects who have positive serum ßHCG pregnancy test taken within 7 days of PV-10 treatment.
- Fertile subjects who are not using effective contraception.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States4 sites
St Luke's Hospital & Health Network
Bethlehem, Pennsylvania, 18015
M.D. Anderson Cancer Center
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
California Pacific Medical Center
San Francisco, California, 94115
Australia3 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Sydney Melanoma Unit
Sydney, New South Wales, 2050
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
About this study
Official title: A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma
The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection.
Read the detailed description
This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.
To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.
- Conditions
- Melanoma
- Being tested
- PV-10 (10% rose bengal disodium)
- Keywords
- immune, vaccine, systemic, Metastatic Melanoma (AJCC Stage III or IV)
- Medical subject headings
- Melanoma
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
| Study group | Role | What they receive |
|---|---|---|
| PV-10 | Experimental | Not described Receives: Drug: PV-10 (10% rose bengal disodium) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) of PV-10 Treated Lesions
Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.
Measured: 52 weeks
Secondary outcomes (3)
Objective Response Rate of Untreated Bystander Lesions
Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for designated, untreated cutaneous or subcutaneous bystander lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all bystander lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of bystander lesions; Objective Response Rate (ORR) = %CR + %PR.
Measured: 52 weeks
Progression Free Survival (PFS)
Progression is defined using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or significant worsening of non-target disease (e.g., a measurable increase in non-target lesions or the appearance of new lesions) indicative of disease progression.
Measured: 52 weeks
Overall Survival
1-year survival
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionMay 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provectus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John F Thompson, MD, Principal investigator, Sydney Melanoma Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521053
- Sponsor's protocol ID
- PV-10-MM-02
- Status last verified
- Aug 2014
- First submitted
- 24 Aug 2007
- Last updated
- 25 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00521053
- Acronym / sponsor ID
- PV-10-MM-02
- Conditions
- Melanoma
- Keywords
- immune, vaccine, systemic, Metastatic Melanoma (AJCC Stage III or IV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Provectus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Posted 25 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to investigate the effectiveness of intralesional (IL) PV-10 for locoregional treatment of metastatic melanoma. This study will also include assessment of response in untreated bystander lesions following intralesional injection of PV-10 into targeted lesions. Additional objectives are to determine the safety profile of PV-10 following intralesional injection, and assess the pharmacokinetic profile of PV-10 in the bloodstream following intralesional injection.
Detailed description
This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.
To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PV-10 | Experimental | Drug: PV-10 (10% rose bengal disodium) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Men or women, age 18 years or older.
- Histologically or cytologically confirmed metastatic melanoma, AJCC (2002) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis).
- Measurable disease in at least one lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound. Target, Non-Target and Bystander Lesions selected by discretion of Investigator.
- Performance Status: ECOG 0-2.
- Life Expectancy: At least 6 months.
Key exclusion criteria (17 listed)
- Radiation therapy within 4 weeks of study treatment or to any Study Lesion within 12 weeks of study treatment.
- Chemotherapy:
- Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks of study treatment.
- Investigational agents within 4 weeks (or 5 half-lives) of study treatment.
- Photosensitizing agents within 5 half-lives of study treatment.
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 | Drug | PV-10 |
Primary outcome
Objective Response Rate (ORR) of PV-10 Treated Lesions
Time frame: 52 weeks
Using modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for cutaneous or subcutaneous target lesions assessed by ruler, caliper or ultrasound: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate (ORR) = %CR + %PR.
3 secondary outcomes
Objective Response Rate of Untreated Bystander Lesions
Time frame: 52 weeks
Progression Free Survival (PFS)
Time frame: 52 weeks
Overall Survival
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John F Thompson, MD principal investigator
Sydney Melanoma Unit
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PV-10 (10% rose bengal disodium) in people with Melanoma, run by Provectus Pharmaceuticals at 7 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 21 inclusion and 17 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: finished, as of the sponsor's last update on 25 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Objective Response Rate (ORR) of PV-10 Treated Lesions (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
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 25 Aug 2014.