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

Phase 1
18 Years
85 Years
Not Enrolling

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Trial Information

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

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.

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.

Type of Study:


Study Design:

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

Outcome Measure:

Safety: adverse experience

Principal Investigator

Eric Wachter, Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Provectus Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

August 2005

Completion Date:

August 2007

Related Keywords:

  • Melanoma
  • Stage III and IV melanoma
  • Melanoma