Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00219843
Status:
COMPLETED
Last Update Posted:
2007-08-23
First Post:
2005-09-14
Brief Title:
Intralesional PV-10 Chemoablation of Metastatic Melanoma
Sponsor:
Provectus Pharmaceuticals
Organization:
Provectus Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Safety and Tolerability Study of Intralesional PV-10 Chemoablation in Subjects With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None