Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes
Condition: Breast Cancer; Melanoma
MeSH terms: Breast Neoplasms; Melanoma
Intervention: Lymphoseek
Intervention description: The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lymphoseek; Breast Cancer; Melanoma; Experimental

Summary:

      Data from this pivotal clinical trial will be used to support a marketing application (i.e.,
      NDA) of Navidea's Lymphoseek for use in anatomical delineation of lymphoid tissue (nodes) in
      the lymphatic pathway draining the primary site of a tumor.

      Multicenter, open-label, within-patient comparative study of Lymphoseek and vital blue dye in
      the detection of excised lymph nodes in patients with known melanoma and breast cancer. All
      patients will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc
      99m and vital blue dye.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient has provided written informed consent with HIPAA authorization.

          2. The patient is a candidate for surgical intervention, with lymph node mapping being a
             part of the surgical plan.

          3. The patient is at least 18 years of age at the time of consent.

          4. The patient has an ECOG performance status of Grade 0 - 2 (see Appendix A).

          5. 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).

          6. 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

          7. The patient has a diagnosis of primary melanoma. Breast Cancer Patients

          8. The patient has a diagnosis of primary breast cancer.

          9. Patients with pure ductal carcinoma in situ (DCIS) or non-invasive carcinoma if lymph
             node biopsy is part of the surgical plan.

        Exclusion Criteria:

          1. The patient is pregnant or lactating.

          2. 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).

          3. The patient has a known hypersensitivity to Lymphazurin.

          4. The patient has participated in another investigational drug study within 30 days of
             scheduled surgery.

             Melanoma Patients

          5. The patient has a tumor with a Breslow depth less than 0.75mm.

          6. Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.

          7. 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.

          8. Patient has undergone node basin surgery of any type or radiation to the nodal
             basin(s) potentially draining the primary melanoma.

          9. 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

         10. The patient has bilateral primary breast cancers or multiple tumors within their
             breast.

         11. Patient has had prior surgical procedures such as breast implants, reduction
             mammoplasty, or axillary surgery.

         12. Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the
             contraindicated breast will not undergo lymph node mapping.

         13. Patient has had preoperative radiation therapy to the affected breast or axilla.