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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00521053




Registration number
NCT00521053
Ethics application status
Date submitted
24/08/2007
Date registered
27/08/2007
Date last updated
25/08/2014

Titles & IDs
Public title
Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma
Scientific title
A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma
Secondary ID [1] 0 0
PV-10-MM-02
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 (10% rose bengal disodium)

Experimental: PV-10 -


Treatment: Drugs: PV-10 (10% rose bengal disodium)
Intralesional injection for chemoablation

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

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
52 weeks
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
52 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
52 weeks
Secondary outcome [3] 0 0
Overall Survival - 1-year survival
Timepoint [3] 0 0
52 weeks

Eligibility
Key inclusion criteria
- 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:

- 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
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 2
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
Sydney Melanoma Unit - Sydney
Recruitment hospital [2] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Kentucky
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas

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

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT00521053
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John F Thompson, MD
Address 0 0
Sydney Melanoma Unit
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
Other publications