Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma

PRIMARY OBJECTIVES:

I. To determine if the alterations in morphology and phenotype to the sentinel lymph nodes
are reversible.

II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes
results in diminished regional tumor burden.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing
sentinel lymph node biopsy.

ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph
node biopsy.

After completion of study treatment, patients are followed up for 30 days.

Inclusion Criteria:

- Patients with stage IB or II cutaneous melanoma

- Primaries on the torso, upper and lower extremities and head and neck region

- Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of
initial entry into the study

- Bilirubin < 2.0 ng/dl

- Creatinine < 3.0 ng/dl

- Able to understand the consent competent to sign

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

- Prior wide excision with diameter of the excision > 3 cm

- Primary melanoma arises from the eye or mucus membranes

- Clinical evidence of regional, intransit ,or distant metastases

- Second invasive melanoma

- Prior surgical procedures that would alter the drainage patterns and would prevent us
from identifying sentinel lymph nodes (SN)

- Patients with primary or secondary immunodeficiencies

- Pregnancy

- Known allergy to sargramostim (GM-CSF)

- History of cardiac disease, in particular, supraventricular tachycardia