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

Completed · Phase 3

Conditions studied: Breast Cancer, Melanoma

In brief

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.

Key facts

Study ID

NCT00671918

Run by

Navidea Biopharmaceuticals

People needed

186

Starts

2008-04-01

Expected to finish

2009-07-01

Last updated by the study team

2013-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Barbara Michna, M.D — Alexander City, Alabama, United States
• Helen Krontiras, M.D. — Birmingham, Alabama, United States
• Anne Wallace, M.D. — La Jolla, California, United States
• Ken Deck, M.D. — Laguna Hills, California, United States
• Steve Martinez, M.D. — Sacramento, California, United States
• Mark Faries, M.D. — Santa Monica, California, United States
• Eli Avisar, M.D. — Miami, Florida, United States
• Charles Cox, M.D. — Tampa, Florida, United States
• Vernon Sondak, M.D. — Tampa, Florida, United States
• Julian Kim, M.D. — Cleveland, Ohio, United States
• Bruce Averbook, M.D — Cleveland, Ohio, United States
• Stephen Povoski, M.D. — Columbus, Ohio, United States
• Thomas Frazier, M.D. — Bryn Mawr, Pennsylvania, United States
• Ned Carp, M.D. — Philadelphia, Pennsylvania, United States
• Schlomo Schneebaum, M.D. — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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