Clinical trial · Interventional
Intralesional PV-10 Chemoablation of Metastatic Melanoma
A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
NCT00219843CI-TRIAL-00000849completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PV-10 (rose bengal disodium, 10%) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety: adverse experience
Secondary outcomes (1)
- measure
- Efficacy: objective response rate of target lesions and untreated non-target lesions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.