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

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:

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

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

     1. AST, ALT, Bilirubin, and Alk phos within normal limits,
     2. LDH up to 1.2 x ULN
  5. Renal:

     1. 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.