NCT00219843

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 Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Typical duration for phase_1

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

September 14, 2005

Last Update Submit

August 22, 2007

Conditions

Melanoma

Keywords

Stage III and IV melanoma

Outcome Measures

Primary Outcomes (1)

  • Safety: adverse experience

Secondary Outcomes (1)

  • Efficacy: objective response rate of target lesions and untreated non-target lesions

Interventions

PV-10 (rose bengal disodium, 10%)DRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +4 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sydney Melanoma Unit

North Sydney, New South Wales, 2060, Australia

Location

Newcastle Melanoma Unit

Waratah, New South Wales, 2298, 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

Study Officials

  • Eric Wachter, Ph.D.

    Provectus Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

August 1, 2005

Study Completion

August 1, 2007

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

AU(2)