Intralesional PV-10 Chemoablation of Metastatic Melanoma

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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 Design

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

Related Conditions & MeSH terms

Melanoma

Clinical Trial Details

NCT number	NCT00219843
Study type	Interventional
Source	Provectus Pharmaceuticals
Contact
Status	Completed
Phase	Phase 1
Start date	August 2005
Completion date	August 2007

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05094804` - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents	Phase 1/Phase 2
Completed	`NCT03979872` - Risk Information and Skin-cancer Education for Undergraduate Prevention	N/A
Recruiting	`NCT04986748` - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation	`NCT00068003` - Harvesting Cells for Experimental Cancer Treatments
Recruiting	`NCT05707286` - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting	`NCT05470283` - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma	Phase 1
Recruiting	`NCT05077137` - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy	Phase 1
Active, not recruiting	`NCT02721459` - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma	Phase 1
Completed	`NCT00341939` - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting	`NCT05839912` - Excision of Lymph Node Trial (EXCILYNT) (Mel69)	N/A
Recruiting	`NCT04971499` - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma	Phase 1/Phase 2
Recruiting	`NCT05263453` - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation	Phase 2
Active, not recruiting	`NCT05060432` - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06413680` - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies	Phase 1/Phase 2
Completed	`NCT03348891` - TNF in Melanoma Patients Treated With Immunotherapy	N/A
Terminated	`NCT03399448` - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells)	Phase 1
Completed	`NCT03171064` - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment	Phase 2
Not yet recruiting	`NCT05539118` - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma	Phase 1/Phase 2
Recruiting	`NCT05171374` - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn	`NCT02854488` - Yervoy Pregnancy Surveillance Study