Evaluation of the Effects of Local GM-CSF-in-Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes
Regimen: Each injection will be administered to patients with clinical stage I or II
melanoma, who have had complete excision of a primary melanoma, but prior to wide excision
with or without sentinel node biopsy as definitive surgical therapy.
In Stage 1: Patients will be injected with a 1 ml emulsion containing GM-CSF in saline plus
Montanide ISA-51 adjuvant, in skin adjacent to a melanoma biopsy scar.
In Stage 2: Patients will be randomized to receive an injection of one of the following in
skin adjacent to the melanoma biopsy scar:
1. 1 ml saline
2. GM-CSF in 1 ml saline
3. an emulsion of Montanide ISA-51 adjuvant and saline
4. an emulsion of GM-CSF in saline plus ml Montanide ISA-51 adjuvant. All vaccines will be
administered intradermally. After the injection, each patient will undergo wide
excision of the melanoma site, with or without sentinel node biopsy, as clinically
indicated.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Yes
Craig L Slingluff, MD
Principal Investigator
University of Virginia
United States: Food and Drug Administration
8380
NCT00912574
June 2004
Name | Location |
---|---|
University of Virginia | Charlottesville, Virginia 22908 |