Inclusion Criteria:

- Eligible patients will be males or females with histologically proven melanoma.
Patients must have Stage II (T4), III, and IV malignant melanoma surgically resected
with no clinical evidence of disease by clinical, laboratory criteria or radiologic
examination as defined below.

- Individuals must be at least 14 years of age.

- Pregnant women are not eligible. Men and women will be required to use an effective
form of contraception.

- Patients requiring corticosteroid therapy or are receiving other forms of
immunotherapy are not eligible.

- Patients may have received immunotherapy for prior disease. They must have completed
therapy at least one month prior to study entry. Patients may not have received prior
chemotherapy or therapy with GM-CSF. Patients are permitted to receive adjuvant
radiation therapy but these patients will not be selected as part of the sub-set
undergoing studies of cellular immunologic responses since the radiation could alter
these responses. Based on the reults from one randomized, controlled clinical trial,
the LEUKINE product labeling contains the following contraindication: “Due to the
potential sensitivity of rapidly dividing hematopoietic progenitor cells, LEUKINE
should not be administered simultaneously with cytoxic chemotherapy or radiotherapy
or within 24 hours preceding or following chemotherapy or radiotherapy. In one
controlled study, patients with small cell lung cancer received LEUKINE and
concurrent thoracic radiotherapy and chemotherapy or the identical radiotherapy and
chemotherapy without LEUKINE. The patients randomized to LEUKINE had significantly
higher incidence of adverse events, including higher mortality and a higher incidence
of grade 4 infections and grade 3 or 4 thrombocytopenia.28” Other investigators have
reported that CM-CSF can be given safely with concurrent radiation therapy. These
contrasting results may be related to differences in the patient populations or
intensity and/or location of the site of radiotherapy in the body, among other
factors. GM-CSF has been administered safely in combination with radiation therapy
for treatment of head and neck cancers29,30 and has been used safely during regimens
that combine chemotherapy and radiation therapy.31

- Patients must undergo examination for evidence of residual disease, including
physical examination, CBC, chemistry panel, CT scan of the chest and abdomen (and
pelvis for lower extremity or lower trunk lesions), and single sequence with
gadolinium MRI or CT of the brain. A PET scan may be substituted for the CT of the
chest and abdomen (and pelvis). These tests must be negative for residual disease
before entry into the study.

- Administration of the protocol medication must be initiated within 90 days of the
definitive surgical excision rendering the patient NED.

Exclusion Criteria:

- Patients not meeting Inclusion Criteria described above