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Clinical Trial Summary

Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional lymph node immunity


Clinical Trial Description

The sentinel lymph nodes in patients with melanoma are immunosuppressed and the investigators have shown this occurs early in the disease process. This regional nodal immunosuppression precedes nodal metastasis and may be required for nodal spread. Administration of GM-CSF has been used to alter the immune response to metastatic melanoma. The investigators propose to assess whether administration of a short course of GM-CSF preoperatively to patients about to undergo wide local excisions and sentinel lymph node dissection can alter the immune environment of the sentinel lymph node and restore an immune surveillance profile in the sentinel lymph node. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02451488
Study type Interventional
Source Mayo Clinic
Contact
Status Completed
Phase Phase 4
Start date May 2015
Completion date November 4, 2016

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