Goal: To characterize the cellular events that occur in vivo after vaccination with an emulsion of GMCSF-in-adjuvant. Design: Open-label, single dose study in two stages.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml 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 at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml 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 at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
University of Virginia
Charlottesville, Virginia, United States
Number of dendritic cells (total and mature) accumulating in the dermis after administration of the adjuvant
Proportion of the sentinel node occupied by dendritic cells (total and mature)
Time to maximal dendritic cell infiltration into the dermis
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For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml 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 at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
For each injection, patients will receive the following: In stage 1: Patients will be injected with a 1 ml emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml 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 at one of two time points: 1. 1 ml saline 2. specified dose of GM-CSF in 1 ml saline 3. an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline 4. an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant