Intralesional PV-10 Chemoablation of Metastatic Melanoma
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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
Drug: PV-10 (rose bengal disodium, 10%)
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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Ages Eligible for Study:
18 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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
Creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.0 mg/dL
AST/ALT ≤ 3 times the upper limit of normal (ULN)
No major cardiovascular disease
T3 (serum triiodothyronine), T4 (serum thyroxine) and THS (serum thyrotropin) within normal limits
Adequate immune system function in the opinion of the investigator
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
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
Subjects taking medications with a significant risk of photosensitization, such as thiazides, within one week (or 5 half-lives) of study treatment.