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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/NCT00219843




Registration number
NCT00219843
Ethics application status
Date submitted
14/09/2005
Date registered
22/09/2005
Date last updated
23/08/2007

Titles & IDs
Public title
Intralesional PV-10 Chemoablation of Metastatic Melanoma
Scientific title
A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
Secondary ID [1] 0 0
PV-10-MM-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

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%)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety: adverse experience
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Efficacy: objective response rate of target lesions and untreated non-target lesions
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- 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

- 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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:

- 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.

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
Single group
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
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney Melanoma Unit - North Sydney
Recruitment hospital [2] 0 0
Newcastle Melanoma Unit - Waratah
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah

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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00219843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eric Wachter, Ph.D.
Address 0 0
Provectus Pharmaceuticals
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/NCT00219843