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Intralesional PV-10 Chemoablation of Metastatic Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00219843
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 23, 2007
Information provided by:
Provectus Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: PV-10 (rose bengal disodium, 10%) Phase 1

Detailed Description:
This is a two center, open label, ascending dose study. Subjects with at least two measurable melanoma lesions will receive a single intralesional injection of 10% PV-10 solution into each of one to twenty (20) target lesions. Additionally, one to three measurable untreated non-target lesions will be followed for assessment of bystander response. Systemic and locoregional adverse events will be monitored over the study interval. Dose escalation will be made only if no subjects at the first dose level have a Grade 3 non-hematological or Grade 4 hematological toxicity over a period of two weeks after PV-10 administration. Subject accrual and PV-10 administration at the second dose level will be stopped if more than 1 subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity within a period of two weeks after PV-10 administration.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
Study Start Date : August 2005
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Safety: adverse experience

Secondary Outcome Measures :
  1. Efficacy: objective response rate of target lesions and untreated non-target lesions

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219843

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Australia, New South Wales
Sydney Melanoma Unit
North Sydney, New South Wales, Australia, 2060
Newcastle Melanoma Unit
Waratah, New South Wales, Australia, 2298
Sponsors and Collaborators
Provectus Pharmaceuticals
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Study Director: Eric Wachter, Ph.D. Provectus Pharmaceuticals
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ClinicalTrials.gov Identifier: NCT00219843    
Other Study ID Numbers: PV-10-MM-01
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: August 2007
Keywords provided by Provectus Pharmaceuticals:
Stage III and IV melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas