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CompletedNCT00521053Updated Aug 25, 2014Results posted

Phase 2 Study of Intralesional PV-10 for Metastatic Melanoma

A Phase 2 interventional study of PV-10 (10% rose bengal disodium) in Melanoma, sponsored by Provectus Pharmaceuticals. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-25.

Sponsored by Provectus Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This is a multicenter, open-label, single-agent study. Subjects with at least one melanoma lesion ≥ 0.2 cm in diameter that can be accurately measured by ruler/caliper or ultrasound will receive intralesional injection of PV-10 into each of up to twenty (20) Study Lesions. Additionally, one to two measurable Bystander Lesions may remain untreated and will be followed for assessment of bystander response.

To accurately reflect anticipated clinical use, repeat dosing of treated lesions will be allowed at the Investigator's discretion at weeks 8, 12 and 16 following initial treatment for those lesions not exhibiting complete response. Subjects will be followed for 52 weeks following initial treatment with PV-10.

02

Conditions studied

  • Melanoma

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Keywords

  • immune
  • vaccine
  • systemic
  • Metastatic Melanoma (AJCC Stage III or IV)
03

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 80 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

Provectus Pharmaceuticals is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    PV-10

    Drug: PV-10 (10% rose bengal disodium)

Interventions

  • DrugPV-10 (10% rose bengal disodium)

    Intralesional injection for chemoablation

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 52 weeks

Secondary outcomes

  1. 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.

    Time frame: 52 weeks

  2. 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.

    Time frame: 52 weeks

  3. Overall Survival

    1-year survival

    Time frame: 52 weeks

07

Results

Posted Aug 25, 2014

Participant flow

Treatment Phase
Participant flow — Treatment Phase
MilestonePV-10
Started80
Received 1 cycle of pv-1035
Received 2 cycles of pv-1026
Received 3 cycles of pv-1016
Received 4 cycles of pv-103
Completed80
Not completed0
Observation Phase
Participant flow — Observation Phase
MilestonePV-10
Started80
Completed12
Not completed68
Withdrew: Disease progression55
Withdrew: Additional pv-10 via alternate protocol8
Withdrew: Death2
Withdrew: Adverse event1
Withdrew: Other non-study melanoma treatment1
Withdrew: Physician decision1

Outcome measures

PrimaryObjective 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.

Time frame:
52 weeks
Reported as:
Number · percentage of participants
Objective Response Rate (ORR) of PV-10 Treated Lesions
percentage of participantsPV-10
Objective Response Rate (ORR) of PV-10 Treated Lesions51.3 (39.8 to 62.6)
SecondaryObjective 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.

Time frame:
52 weeks
Reported as:
Number · percentage of participants
Objective Response Rate of Untreated Bystander Lesions
percentage of participantsPV-10
Objective Response Rate of Untreated Bystander Lesions33.3 (19.6 to 49.6)
SecondaryProgression 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.

Time frame:
52 weeks
Reported as:
Median · Months
Progression Free Survival (PFS)
MonthsStage IIIStage IV
Progression Free Survival (PFS)3.7 (2.9 to 4.5)1.9 (1.6 to 2.1)
Post-hocRate of Complete Response

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; Complete Response Rate (CRR) = %CR.

Time frame:
52 weeks
Reported as:
Number · percentage of participants
Rate of Complete Response
percentage of participantsAll Lesions Treated
Rate of Complete Response50 (30.6 to 69.4)
SecondaryOverall Survival

1-year survival

Time frame:
52 weeks
Reported as:
Number · percentage of participants
Overall Survival
percentage of participantsStage IIIStage IV
Overall Survival89 (1.25 to 13.38)39

Adverse events

Collected over Adverse event data were collected over the study interval (52 weeks) and followed until resolution. Events on-going at time of withdrawal were followed until resolution or for a period of at least 28 days from last dose of study medication.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PV-10—14/80 (17.5%)80/80 (100%)
Most frequent serious events
Showing 10 of 19
Most frequent serious events
EventPV-10
Injection site swellingGeneral disorders2/80
PneumoniaInfections and infestations2/80
Injection site painGeneral disorders2/80
Left ventricular hypertrophyCardiac disorders1/80
CholecystitisHepatobiliary disorders1/80
Injection site oedemaGeneral disorders1/80
Injection site ulcerGeneral disorders1/80
PyrexiaGeneral disorders1/80
Viral infectionInfections and infestations1/80
Injection site necrosisGeneral disorders1/80
Most frequent other events
Showing 10 of 28
Most frequent other events
EventPV-10
Injection site painGeneral disorders65/80
Injection site oedemaGeneral disorders32/80
Injection site vesiclesGeneral disorders30/80
Injection site discolourationGeneral disorders25/80
Injection site swellingGeneral disorders20/80
NauseaGastrointestinal disorders17/80
Injection site pruritusGeneral disorders17/80
HeadacheNervous system disorders14/80
Injection site erythemaGeneral disorders11/80
ConstipationGastrointestinal disorders10/80

Baseline characteristics

Age, Continuous
Age, Continuous(years)PV-10
Median70.0 (33 to 97)
Sex: Female, Male
Sex: Female, Male(Participants)PV-10
Female32
Male48
Region of Enrollment
Region of Enrollment(participants)PV-10
United States27
Australia53
American Joint Committee on Cancer (AJCC) Stage at Baseline
American Joint Committee on Cancer (AJCC) Stage at Baseline(participants)PV-10
IIIB38
IIIC24
M1a3
M1b5
M1c10
Tumor Burden in Skin
Tumor Burden in Skin(participants)PV-10
Less than 10 Lesions44
10 or more Lesions29
Too Numerous to Count7
Prior Interventions
Prior Interventions(participants)PV-10
Excision80
Nodal Biopsy50
Regional Chemotherapy19
Immunotherapy17
Radiotherapy17
Investigational Agents11
Systemic Chemotherapy10
Distal Amputation7
Other6
Number of Prior Interventions
Number of Prior Interventions(prior interventions)PV-10
Median6 (1 to 19)
Eastern Cooperative Oncology Group (ECOG) Performance Status
Eastern Cooperative Oncology Group (ECOG) Performance Status(participants)PV-10
053
125
22

1 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • California Pacific Medical Center
    San Francisco, California 94115, United States
  • University of Louisville
    Louisville, Kentucky 40202, United States
  • St Luke's Hospital & Health Network
    Bethlehem, Pennsylvania 18015, United States
  • M.D. Anderson Cancer Center
    Houston, Texas 77030, United States
  • Sydney Melanoma Unit
    Sydney, New South Wales 2050, Australia
  • Princess Alexandra Hospital
    Woolloongabba, Queensland 4102, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00521053
Lead sponsor
Provectus Pharmaceuticals
Responsible party
Sponsor
First posted
Aug 27, 2007
Start date
Sep 2007
Primary completion
May 2010
Completion
Jun 2012
Results posted
Aug 25, 2014
Last update
Aug 25, 2014

Study contacts

John F Thompson, MD
principal investigator · Sydney Melanoma Unit

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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