Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes
II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes
results in diminished regional tumor burden.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing
sentinel lymph node biopsy.
ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph
After completion of study treatment, patients are followed up for 30 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Reversal of alterations in the SN
A series of analysis of variance (ANOVA) models will be employed.
Up to 30 days
Jonsson Comprehensive Cancer Center
United States: Federal Government
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