A Phase 1 interventional study of EF5 Hypoxia in Melanoma, sponsored by Douglas Tyler. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-09.
Sponsored by Douglas Tyler · Phase 1, Interventional, and Diagnostic
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.
3,006 studies on the registry are indexed under Melanoma; 519 are open to participants now.
This study's enrollment of 15 is below the median of 38 across 2,350 interventional studies indexed under Melanoma.
Browse Melanoma studies →Douglas Tyler is the lead sponsor of 2 studies on the registry; none are open to participants now.
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3.2. Exclusion criteria
EF5 administered at 21mg/kg
Drug: EF5 Hypoxia
EF5 is a dye used to measure hypoxia
Spatial comparison between marker proteins and hypoxia.
We will describe the distribution of the markers at each of the three time points with boxplots and means (with 80% confidence intervals). The variance of each marker will be partitioned into three parts: variance due to the time (i.e., treatment) effect, variance among patients, and error variance. This calculation can easily be done by fitting a general linear model in which marker is regressed on an n-1 degree of freedom patient effect (where n is the number of patients) and a 2 degree of freedom time effect. The error variance with 2\*(n-1) degrees of freedom is of course equal to the variance of the interaction of patient with time. Obviously, we would hope to find that the variance for the time effect is larger than either of the other two variances.
Time frame: 2 years
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Douglas Tyler