Trial of Lymphoseek in Intraoperative Localization of Lymph Nodes in Breast Cancer and Melanoma

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navidea Biopharmaceuticals
• Treatments: Dextrans; Technetium Tc 99m Pentetate

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