NCT00912574 - 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 | Biotech Hunter

Enrollment

29

Participants

Timeline

Start Date

June 30, 2004

Primary Completion Date

July 31, 2008

Conditions

Melanoma

Interventions

DRUG

GM-CSF-in-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"

DRUG

Montanide ISA-51

"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"

BIOLOGICAL

GM-CSF and Montanide ISA-51

"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"

DRUG

Saline

"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"

Trial Locations (1)

22908

University of Virginia, Charlottesville