Evaluation of the Effects of Local Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Adjuvant Administration on Dendritic Cells in Skin of Melanoma Patients and in Sentinel Lymph Nodes: MEL38
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): GM-CSF-in-adjuvant; Montanide ISA-51; GM-CSF and Montanide ISA-51; Saline
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): 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 ml saline
specified dose of GM-CSF in 1 ml saline
an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
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 ml saline
specified dose of GM-CSF in 1 ml saline
an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
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 ml saline
specified dose of GM-CSF in 1 ml saline
an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
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 ml saline
specified dose of GM-CSF in 1 ml saline
an emulsion of 0.5ml Montanide ISA-51 adjuvant and 0.5 ml saline
an emulsion of specified dose of GM-CSF in 0.5 ml saline plus 0.5 ml Montanide ISA-51 adjuvant
Intervention MeSH terms: Molgramostim; Sargramostim; Monatide (IMS 3015); Freund's Adjuvant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melanoma; adjuvant; dendritic cells; vaccine