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

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 ml saline
• GM-CSF in 1 ml saline
• an emulsion of Montanide ISA-51 adjuvant and saline
• 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.

Inclusion criteria

• Patients who have been diagnosed, by histologic and clinical examination, with resected AJCC stage I or II melanoma.
• Patients who have any evidence of metastasis will not be eligible.
• All patients must have:

• Karnofsky performance of 80% or higher
• ECOG performance status of 0 or 1
• Ability and willingness to give informed consent
• Laboratory parameters as follows:

• ANC: 90% of lower limit of normal (LLN) to 120% of upper limit of normal (ULN)
• Platelets: 100-500 x 103/uL
• Hgb: 90% LLN to 120% ULN
• Hepatic:

• AST, ALT, Bilirubin, and Alk phos within normal limits,
• LDH up to 1.2 x ULN
• Renal:

• Creatinine up to 1.5 x ULN
• Age 18-85 years at the time of study entry.

Exclusion criteria

• Patients who are currently receiving cytotoxic chemotherapy, interferon, or radiation or who have received this therapy within the preceding 12 weeks.
• Patients with known or suspected allergies to any component of the vaccine.
• Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:

• Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents),
• Allergy desensitization injections,
• Corticosteroids, administered parenterally or orally. Topical corticosteroids are acceptable.
• Any growth factors, Interleukin-2 or other interleukins.
• Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the injection.
• Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator.
• Patients classified according to the New York Heart Association classification as having Class III or IV heart disease.
• Patients with serious symptomatic active pulmonary disease, with pleural effusions, or with a history of pulmonary edema.
• Patients who have systemic autoimmune disease with visceral involvement.
• Patients with clinically apparent skin infection or other clinically evident inflammation involving the skin adjacent to the melanoma biopsy scar.