Targeted Silica Nanoparticles in Imaging Sentinel Lymph Nodes in Patients with Newly-Diagnosed and/or Recurrent Melanoma or Oral Cavity Squamous Cell Cancer

Inclusion Criteria

• Histologically confirmed diagnosis of melanoma at Memorial Sloan-Kettering Cancer Center (MSKCC)
• Have one of the following disease histories: * Newly-diagnosed or recurrent (local, regional, metastatic) malignant melanoma, or patients with oral cavity or cutaneous squamous cell carcinoma in whom SLN mapping is indicated; these patients are clinically node negative by history, physical examination, and imaging ** Residual clinically or radiographically evident tumor, including primary cutaneous and mucosal melanomas ** Prior radiation therapy, chemotherapy, or surgery in patients requiring flap reconstruction in the head and neck region ** Newly-diagnosed patients with previous excisional biopsy
• At the discretion of the physician or surgeon, normal baseline cardiac function based upon pre-operative evaluation
• At the discretion of the physician or surgeon, absolute neutrophil count (ANC) > 1000/mcl
• At the discretion of the physician or surgeon, platelets > 100,000/mcl
• At the discretion of the physician or surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert’s)
• For melanoma patients, if patients have a history of malignancy other than melanoma and other skin cancers in the past five years, their inclusion is up to the discretion of the physician
• All patients of childbearing and child-creating age must be using an acceptable form of birth control
• Women who are pre-menopausal must have a negative serum pregnancy test

Exclusion Criteria

• Known pregnancy or breast-feeding
• Known allergies to polyethylene glycol (PEG)-containing products (bowel preparations, laxatives) or PEG allergy
• Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the agent; this includes patients with uncontrolled infection, chronic renal insufficiency, myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association classification III or IV heart disease