Intralesional PV-10 Chemoablation of Metastatic Melanoma

August 22, 2007 updated by: Provectus Pharmaceuticals

A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • North Sydney, New South Wales, Australia, 2060
        • Sydney Melanoma Unit
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Melanoma Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety: adverse experience

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Provectus Pharmaceuticals

Investigators

  • Study Director: Eric Wachter, Ph.D., Provectus Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 22, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PV-10-MM-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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