MelanomaPhase 1NCT00219843
Intralesional PV-10 Chemoablation of Metastatic Melanoma
A Phase 1 study testing PV-10 (rose bengal disodium, 10%) in people with Melanoma, run by Provectus Pharmaceuticals at 2 sites in Australia.
Trial summary
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of metastatic melanoma. This study will also include a preliminary assessment of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks following IL PV-10 treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma
- What is being tested?
- PV-10 (rose bengal disodium, 10%)
- How many people
- 20 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2005to Aug 2007
- Phase
- Phase 1
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed metastatic melanoma, American Joint Committee on Cancer (AJCC) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis)
- Measurable disease in at least two lesions, each lesion ≤ 6 cm in diameter
- Performance status: ECOG 0-2
- Life expectancy: at least 6 months
- Hematopoietic:
- White blood cell count (WBC) at least 3000/mm3
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- Absolute neutrophil count (ANC) at least 1.5 (1,500/mm3)
- Platelet count at least 100,000/mm3
- Renal function:
- Creatinine ≤ 2.0 mg/dL
- Hepatic function:
- Bilirubin ≤ 2.0 mg/dL
- AST/ALT ≤ 3 times the upper limit of normal (ULN)
- Cardiovascular function:
- No major cardiovascular disease
- Thyroid function:
- T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits
- Immunological function:
- Adequate immune system function in the opinion of the investigator
Who cannot join
- Radiation therapy within 4 weeks or to any study lesion within 12 weeks
- Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin) or regional chemotherapy (limb infusion or perfusion) within 12 weeks
- Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks
- Investigational agents within 4 weeks (or 5 half-lives)
- Anti-tumor vaccine therapy within 12 weeks
- Concurrent illness:
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- Severe diabetes or extremity complications due to diabetes
- Significant concurrent disease or illness, psychiatric disorders, or alcohol or chemical dependence that would, in the opinion of the investigator, compromise subject safety or compliance or interfere with interpretation of study results
- Thyroid autoregulatory dysfunction, including thyroid disease (subclinical or ongoing), goiter, partial thyroidectomy, prior radioiodine- or surgically-treated Graves' hyperthyroidism, or cystic fibrosis
- Pregnancy or fertile female subjects who are not using effective contraception
- Concurrent medications:
- Subjects taking medications with a significant risk of photosensitization, such as thiazides, within one week (or 5 half-lives) of study treatment.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Sydney Melanoma Unit
North Sydney, New South Wales, 2060
Newcastle Melanoma Unit
Waratah, New South Wales, 2298
About this study
Official title: A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of metastatic melanoma. This study will also include a preliminary assessment of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks following IL PV-10 treatment.
Read the detailed description
This is a two center, open label, ascending dose study. Subjects with at least two measurable melanoma lesions will receive a single intralesional injection of 10% PV-10 solution into each of one to twenty (20) target lesions. Additionally, one to three measurable untreated non-target lesions will be followed for assessment of bystander response. Systemic and locoregional adverse events will be monitored over the study interval. Dose escalation will be made only if no subjects at the first dose level have a Grade 3 non-hematological or Grade 4 hematological toxicity over a period of two weeks after PV-10 administration. Subject accrual and PV-10 administration at the second dose level will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.
- Conditions
- Melanoma
- Being tested
- PV-10 (rose bengal disodium, 10%)
- Keywords
- Stage III and IV melanoma
- 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 (rose bengal disodium, 10%)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: adverse experience
Secondary outcomes (1)
Efficacy: objective response rate of target lesions and untreated non-target lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startAug 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Provectus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Wachter, Ph.D., Study director, Provectus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219843
- Sponsor's protocol ID
- PV-10-MM-01
- Status last verified
- Aug 2007
- First submitted
- 14 Sep 2005
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00219843
- Acronym / sponsor ID
- PV-10-MM-01
- Conditions
- Melanoma
- Keywords
- Stage III and IV melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Provectus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Aug 2007 (actual)
- First posted
- 22 Sep 2005 (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.
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of metastatic melanoma. This study will also include a preliminary assessment of response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24 weeks following IL PV-10 treatment.
Detailed description
This is a two center, open label, ascending dose study. Subjects with at least two measurable melanoma lesions will receive a single intralesional injection of 10% PV-10 solution into each of one to twenty (20) target lesions. Additionally, one to three measurable untreated non-target lesions will be followed for assessment of bystander response. Systemic and locoregional adverse events will be monitored over the study interval. Dose escalation will be made only if no subjects at the first dose level have a Grade 3 non-hematological or Grade 4 hematological toxicity over a period of two weeks after PV-10 administration. Subject accrual and PV-10 administration at the second dose level will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histologically or cytologically confirmed metastatic melanoma, American Joint Committee on Cancer (AJCC) Stage III (regional lymph node metastasis, in-transit metastasis or satellite metastasis) or Stage IV (distant metastasis)
- Measurable disease in at least two lesions, each lesion ≤ 6 cm in diameter
- Performance status: ECOG 0-2
- Life expectancy: at least 6 months
- Hematopoietic:
Key exclusion criteria (12 listed)
- Radiation therapy within 4 weeks or to any study lesion within 12 weeks
- Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin) or regional chemotherapy (limb infusion or perfusion) within 12 weeks
- Local treatment (e.g., surgery, cryotherapy, radiofrequency ablation) to the treatment area within 4 weeks
- Investigational agents within 4 weeks (or 5 half-lives)
- Anti-tumor vaccine therapy within 12 weeks
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 (rose bengal disodium, 10%) | Drug | – |
Primary outcome
Safety: adverse experience
1 secondary outcome
Efficacy: objective response rate of target lesions and untreated non-target lesions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
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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.
Eric Wachter, Ph.D. study director
Provectus Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PV-10 (rose bengal disodium, 10%) in people with Melanoma, run by Provectus Pharmaceuticals at 2 sites in Australia.
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 19 inclusion and 12 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 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety: adverse experience. 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 23 Aug 2007.