Neoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Cutaneous Stage L-lll Melanoma
NCT02451488 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2020-02-10
Summary
Randomized trial to determine if neo-adjuvant subcutaneous GM-CSF restores the host regional lymph node immunity
Conditions
Interventions
- DRUG
-
14 days in a dose of 125 µg/m\^2
- OTHER
-
Standard of Care
No neo-adjuvant therapy prior to surgical intervention
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
James Jakub, MD · Mayo Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2016-11-04
- Completion
- 2016-11-04
- FDA Drug
- Yes
Countries
- United States
Study Locations
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