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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

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

Inclusion Criteria


3.1. Inclusion criteria

- Histologically confirmed AJCC Stage IIIB/IIIC/IV extremity melanoma who are
undergoing ILI or HILP and have tumor available for biopsy (NOTE: patients with only
1 in-transit lesion are NOT eligible)

- Age ≥18

- KPS status ≥ 70

- Bilirubin ≤ 1.5x normal

- Creatinine ≤ 1.8 ( -EF5 is primarily excreted via the kidney)

- WBC > 3000/mm3 and platelets > 100,000/mm3

3.2. Exclusion criteria

- Pregnancy or breast feeding. A negative serum pregnancy test is required of any
women childbearing potential prior to enrollment. Pregnant women are excluded from
this study because EF5 is an agent with potential for teratogenic or abortifacient
effects. Because there is an unknown but potential risk for adverse events in
nursing infants secondary to treatment of the mother with EF5, breastfeeding should
be discontinued if the mother is given EF5.

- Allergy to IV contrast dye

- History of grade III or IV peripheral neuropathy as defined by the NCI CTC (other
2-nitroimidazole compounds are neurotoxic)

- Previous history of any malignancy treated with radiotherapy and/or chemohormonal
therapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Spatial comparison between marker proteins and hypoxia.

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Douglas Tyler, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

DUMC

Authority:

United States: Food and Drug Administration

Study ID:

Pro00033938

NCT ID:

NCT01752257

Start Date:

July 2012

Completion Date:

September 2015

Related Keywords:

  • Melanoma
  • Melanoma
  • Melanoma

Name

Location
Duke University Medical Center Durham, North Carolina  27710