Ignite Creation Date:
2024-05-06 @ 1:12 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01752257
Status:
COMPLETED
Last Update Posted:
2015-03-09
First Post:
2012-10-17
Brief Title:
EF5 in Melanoma Patients
Sponsor:
Douglas Tyler
Organization:
Duke University
Study Overview
Official Title:
Pilot Study to Characterize the HRHV Axis in the Microenvironment of Melanoma in Patients Undergoing Isolated Limb Infusion or Hypothermic Isolated Limb Perfusion With Melphalan
Status:
COMPLETED
Status Verified Date:
2015-03
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 purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress oxidative and nitrosative in the melanoma tumor microenvironment The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia Reactive Species reactive oxygen and nitrogen species HIF-1 and VEGF which the investigators term the HRHV axis Patients with in-transit melanoma AJCC Stage IIIB or IIIC 1 will be administered the hypoxia marker drug EF5 24 hr prior to isolated limb infusion ILI or hyperthermic isolated limb perfusion HILP Tumor biopsies will be performed just prior to ILI or HILP at the 30 minute time point during ILI or 60 minute time point during HILP AND 24 hours after ILI or HILP Tissues obtained will be snap frozen and subsequently analyzed for EF5 binding Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will also be examined The association of the markers with the presence of hypoxia as determined by EF5 positivity will be determined Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in melanoma This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted
Detailed Description:
None
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