Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

Inclusion Criteria

• The patient has provided written informed consent with HIPAA authorization.
• The patient is a candidate for surgical intervention, with lymph node mapping being a part of the surgical plan.
• The patient is at least 18 years of age at the time of consent.
• The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).
• The patient has a clinical negative node status at the time of study entry (i.e. T0-4, N0, M0, see Appendix D and E).
• If of childbearing potential, the patient has a negative pregnancy test within 72 hours prior to administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.

Melanoma Patients

• The patient has a diagnosis of primary melanoma. Breast Cancer Patients
• The patient has a diagnosis of primary breast cancer.
• Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph node biopsy is part of the surgical plan.

Exclusion Criteria

• The patient is pregnant or lactating.
• The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T,N0,M0, see Appendix D and E).
• The patient has a known hypersensitivity to Lymphazurin.
• The patient has participated in another investigational drug study within 30 days of scheduled surgery.

Melanoma Patients

• The patient has a tumor with a Breslow depth less than 0.75mm.
• Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.
• Patient has been diagnosed with a prior invasive melanoma that would occur on the same body region or potentially draining to the same nodal basin or patients with truncal or extremity primary melanoma who has had a prior breast cancer potentially draining to the same axillary nodal basin.
• Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.
• Patient has undergone a wide excision for their primary melanoma (>1 cm in dimension) or complex reconstruction (rotation, free flap, or skin graft of any type).

Breast Cancer Patients

• The patient has bilateral primary breast cancers or multiple tumors within their breast.
• Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.
• Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.
• Patient has had preoperative radiation therapy to the affected breast or axilla.