Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma
Condition: Breast Cancer; Melanoma
MeSH terms: Breast Neoplasms; Melanoma
Intervention: Lymphoseek
Intervention description: Breast Cancer: Intradermal admin of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site OR periareolar administration of Lymphoseek: Inject 0.2-.04 mL in multiple divided doses at the margin of the areola OR subareolar administration of Lymphoseek: Inject 0.2-0.4 in multiple divided injections or a single injection in subareolar area as a subcutaneous injection OR peritumor administration of Lymphoseek: Inject 2.0-4.0 mL in multiple divided injections, intraparenchemally surrounding the tumor or biopsy cavity. For melanoma pts intradermal administration of Lymphoseek: Inject 0.2-0.4 mL in multiple divided injections or a single injection overlying the intact primary tumor or excision biopsy site.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 186.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; lymph nodes; melanoma; surgery

Summary:

      Data from this pivotal clinical trial will be used to support a marketing application (i.e.,
      NDA) for Navidea's Lymphoseek for use in intraoperative localization of lymph tissue (nodes)
      in the lymphatic pathway draining the primary site of a tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has provided written informed consent with HIPAA authorization before
             participating in the study, as has his/her responsible caregiver, if applicable.

          -  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 [8].

          -  The patient has a clinical negative node status at the time of study entry.

          -  If of child bearing 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.

          -  The patient is currently not participating in another investigational drug study.

        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);

          -  The patient has a known hypersensitivity to Lymphazurin or Patent Bleu V.

        Melanoma Patients

          -  The patient has a tumor with a Breslow depth less than 0.75mm.;

          -  Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy;

          -  Patients 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;

          -  Patients who have undergone node basin surgery of any type or radiation to the nodal
             basin(s) potentially draining the primary melanoma;

          -  Patients who have 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;

          -  Patients that have had prior surgical procedures such as breast implants, reduction
             mammoplasty or axillary surgery;

          -  Patients scheduled for bilateral mastectomy for any reason;

          -  Patients that have had preoperative radiation therapy to the affected breast or axilla