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A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

Phase 2
18 Years
Not Enrolling

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Trial Information

A Phase 2 Study of Intralesional PV-10 in the Treatment of Metastatic Melanoma

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.

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:

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rate (ORR) of PV-10 treated lesions

Outcome Time Frame:

52 weeks

Safety Issue:


Principal Investigator

John F Thompson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sydney Melanoma Unit


United States: Food and Drug Administration

Study ID:




Start Date:

September 2007

Completion Date:

June 2012

Related Keywords:

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



M.D. Anderson Cancer CenterHouston, Texas  77030
California Pacific Medical CenterSan Francisco, California  94115
University of LouisvilleLouisville, Kentucky  40202
St Luke's Hospital & Health NetworkBethlehem, Pennsylvania  18015