Breast CancerPhase 1NCT00237354
PV-10 Chemoablation of Recurrent Breast Carcinoma
A Phase 1 study testing PV-10 (rose bengal disodium 10%) in people with Breast Cancer, run by Provectus Pharmaceuticals at 1 site in New Zealand.
Trial summary
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of recurrent breast carcinoma. This study will also include a preliminary assessment of response of injected lesions by histologic assessment upon lesion excision at 1-3 weeks following IL PV-10 administration. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PV-10 (rose bengal disodium 10%)
- How many people
- 15 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2005to Jul 2008
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy confirmed recurrent soft tissue breast carcinoma
- At least one measurable target lesion at least 0.5 cm and no more than 3 cm in longest diameter
- Performance Status: Karnofsky 70-100% or 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)
- Hemoglobin at least 10 g/dL
- Platelet count at least 100,000/mm3
- Coagulopathy: International Normalized Ratio (INR) at least 1.5.
- Renal Function: Creatinine = 0.05-0.11 mmol/L
- Hepatic Function:
- Bilirubin = 3-21 umol/L
- 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 to study lesions within 4 weeks
- Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin)
- 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, or who are lactating
- Known or suspected brain metastases or spinal cord compression.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma
The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the treatment of recurrent breast carcinoma. This study will also include a preliminary assessment of response of injected lesions by histologic assessment upon lesion excision at 1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.
Read the detailed description
This is a single center, open label, ascending dose study. Subjects with at least one recurrent, histologically confirmed measurable soft tissue breast carcinoma who are candidates for lumpectomy (removal of the lesion from the site of recurrence in the breast or at another site) or mastectomy will receive a single intralesional injection of PV-10 into a single target lesion to uniformly infiltrate the target lesion and up to a 0.5 cm margin at a dose of up to 1.0 mL/cc lesion volume. Systemic and locoregional adverse events will be monitored over the study interval. Subject accrual and PV-10 administration 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
- Breast Cancer
- Being tested
- PV-10 (rose bengal disodium 10%)
- Keywords
- Recurrent soft tissue breast carcinoma
- Medical subject headings
- Breast Neoplasms
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
PV-10 ablation of study lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
Systemic and locoregional adverse experience
Measured: 5-7 weeks post dosing (4 weeks post excision)
Secondary outcomes (2)
Histopathologic response of PV-10 injected lesions
Measured: 7-21 days post dosing
Wound healing of PV-10 injected lesions
Measured: 5-7 weeks post dosing (4 weeks post excision)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Provectus Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Wachter, Ph.D., Study director, Provectus Pharmaceuticals, Inc.Chris Wynne, M.D., Principal investigator, Oncology Service, Christchurch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00237354
- Sponsor's protocol ID
- PV-10-BC-04
- Status last verified
- Oct 2008
- First submitted
- 7 Oct 2005
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma
- ClinicalTrials.gov ID
- NCT00237354
- Acronym / sponsor ID
- PV-10-BC-04
- Conditions
- Breast Cancer
- Keywords
- Recurrent soft tissue breast carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Provectus PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Oct 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 recurrent breast carcinoma. This study will also include a preliminary assessment of response of injected lesions by histologic assessment upon lesion excision at 1-3 weeks following IL PV-10 administration. Post-excision wound healing will be assessed clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.
Detailed description
This is a single center, open label, ascending dose study. Subjects with at least one recurrent, histologically confirmed measurable soft tissue breast carcinoma who are candidates for lumpectomy (removal of the lesion from the site of recurrence in the breast or at another site) or mastectomy will receive a single intralesional injection of PV-10 into a single target lesion to uniformly infiltrate the target lesion and up to a 0.5 cm margin at a dose of up to 1.0 mL/cc lesion volume. Systemic and locoregional adverse events will be monitored over the study interval. Subject accrual and PV-10 administration 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
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Biopsy confirmed recurrent soft tissue breast carcinoma
- At least one measurable target lesion at least 0.5 cm and no more than 3 cm in longest diameter
- Performance Status: Karnofsky 70-100% or ECOG 0-2
- Life Expectancy: At least 6 months
- Hematopoietic:
Key exclusion criteria (11 listed)
- Radiation therapy to study lesions within 4 weeks
- Chemotherapy or other systemic cancer therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin)
- 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%)PV-10 ablation of study lesion | Drug | – |
Primary outcome
Systemic and locoregional adverse experience
Time frame: 5-7 weeks post dosing (4 weeks post excision)
2 secondary outcomes
Histopathologic response of PV-10 injected lesions
Time frame: 7-21 days post dosing
Wound healing of PV-10 injected lesions
Time frame: 5-7 weeks post dosing (4 weeks post excision)
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 24 Oct 2008.
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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, Inc.
Chris Wynne, M.D. principal investigator
Oncology Service, Christchurch Hospital
1 site 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 Breast Cancer, run by Provectus Pharmaceuticals at 1 site in New Zealand.
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 17 inclusion and 11 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 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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?
Systemic and locoregional adverse experience (time frame: 5-7 weeks post dosing (4 weeks post excision)). 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 24 Oct 2008.