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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00237354




Registration number
NCT00237354
Ethics application status
Date submitted
7/10/2005
Date registered
12/10/2005
Date last updated
24/10/2008

Titles & IDs
Public title
PV-10 Chemoablation of Recurrent Breast Carcinoma
Scientific title
A Phase 1 Safety and Tolerability Study of PV-10 Chemoablation of Recurrent Breast Carcinoma
Secondary ID [1] 0 0
PV-10-BC-04
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PV-10 (rose bengal disodium 10%)

Treatment: Drugs: PV-10 (rose bengal disodium 10%)
PV-10 ablation of study lesion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Systemic and locoregional adverse experience
Timepoint [1] 0 0
5-7 weeks post dosing (4 weeks post excision)
Secondary outcome [1] 0 0
Histopathologic response of PV-10 injected lesions
Timepoint [1] 0 0
7-21 days post dosing
Secondary outcome [2] 0 0
Wound healing of PV-10 injected lesions
Timepoint [2] 0 0
5-7 weeks post dosing (4 weeks post excision)

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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:

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2008
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Provectus Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. Post-excision wound healing will be assessed
clinically at 1 week and 4 weeks following excision of PV-10 injected lesions.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00237354
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Wachter, Ph.D.
Address 0 0
Provectus Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00237354