NCT00521053

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 Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2014

Completed
Last Updated

August 25, 2014

Status Verified

August 1, 2014

Enrollment Period

2.7 years

First QC Date

August 24, 2007

Results QC Date

June 12, 2014

Last Update Submit

August 7, 2014

Conditions

Melanoma

Keywords

immunevaccinesystemicMetastatic Melanoma (AJCC Stage III or IV)

Outcome Measures

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.

    52 weeks

Secondary Outcomes (3)

  • Objective Response Rate of Untreated Bystander Lesions

    52 weeks

  • Progression Free Survival (PFS)

    52 weeks

  • Overall Survival

    52 weeks

Study Arms (1)

PV-10

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

Interventions

PV-10 (10% rose bengal disodium)DRUG

Intralesional injection for chemoablation

PV-10

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +6 more criteria

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

California Pacific Medical Center

San Francisco, California, 94115, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

St Luke's Hospital & Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Sydney Melanoma Unit

Sydney, New South Wales, 2050, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Melanoma

Interventions

Rose Bengal

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

FluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPolycyclic Compounds

Results Point of Contact

Title
Eric Wachter, Chief Technology Officer
Organization
Provectus Biopharmaceuticals, Inc.
wachter@pvct.com
1-865-769-4011

Study Officials

  • John F Thompson, MD

    Sydney Melanoma Unit

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2010

Study Completion

June 1, 2012

Last Updated

August 25, 2014

Results First Posted

August 25, 2014

Record last verified: 2014-08

Locations

AU(3)US(4)