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

NCT00671918 | Completed Phase 3 Results

• 1 other identifier: NEO3-05
• Study Type: interventional
• Target: 186
• Locations: 2 countries
• Sites: 15

Brief 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.

Conditions

Breast Cancer; Melanoma

Keywords

breast cancer; lymph nodes; melanoma; surgery

Outcome Measures

Primary Outcomes (1)

• Concordance of Blue Dye and Lymphoseek

  The proportion of lymph nodes detected intraoperatively by blue dye that were also detected by Lymphoseek.

  Surgery after injections of Lymphoseek and blue dye

Secondary Outcomes (1)

• Reverse Concordance of Blue Dye and Lymphoseek

  Surgery after injections of Lymphoseek and blue dye

Study Arms (1)

Lymphoseek, Lymphatic mapping, Injection

EXPERIMENTAL

Drug: Lymphoseek

Interventions

Lymphoseek DRUG

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.

Also known as: technetium Tc 99m tilmanocept

Lymphoseek, Lymphatic mapping, Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (15)

Barbara Michna, M.D

Alexander City, Alabama, 35010, United States

Location

Helen Krontiras, M.D.

Birmingham, Alabama, 35294, United States

Location

Anne Wallace, M.D.

La Jolla, California, 92093, United States

Location

Ken Deck, M.D.

Laguna Hills, California, 92653, United States

Location

Steve Martinez, M.D.

Sacramento, California, 95817, United States

Location

Mark Faries, M.D.

Santa Monica, California, 90404, United States

Location

Eli Avisar, M.D.

Miami, Florida, 33101, United States

Location

Charles Cox, M.D.

Tampa, Florida, 33612, United States

Location

Vernon Sondak, M.D.

Tampa, Florida, 33612, United States

Location

Julian Kim, M.D.

Cleveland, Ohio, 44106, United States

Location

Bruce Averbook, M.D

Cleveland, Ohio, 44109, United States

Location

Stephen Povoski, M.D.

Columbus, Ohio, 43210, United States

Location

Thomas Frazier, M.D.

Bryn Mawr, Pennsylvania, 19010, United States

Location

Ned Carp, M.D.

Philadelphia, Pennsylvania, 19096, United States

Location

Schlomo Schneebaum, M.D.

Tel Aviv, 64239, Israel

Location

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  PMID: 23054107 RESULT

• Wallace AM, Han LK, Povoski SP, Deck K, Schneebaum S, Hall NC, Hoh CK, Limmer KK, Krontiras H, Frazier TG, Cox C, Avisar E, Faries M, King DW, Christman L, Vera DR. Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials. Ann Surg Oncol. 2013 Aug;20(8):2590-9. doi: 10.1245/s10434-013-2887-8. Epub 2013 Mar 17.

  PMID: 23504141 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Results Point of Contact

• Title: Dr. Frederick Cope
• Organization: Navidea Biopharmaceuticals

fcope@navidea.com

614-793-7500

Study Officials

• Richard Orahood, M.D.

  Navidea Biopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 17, 2013
• Results First Posted: June 3, 2013

Record last verified: 2013-06

Locations

US (14); IL (1)