Breast and Melanoma Trial With Lymphoseek to Identify Lymph Nodes

NCT01106040 | Completed Phase 3 Results

• 1 other identifier: NEO3-09
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Breast Cancer; Melanoma

Keywords

Lymphoseek; Breast Cancer; Melanoma; Experimental

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

The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL.

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.
• 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 (see Appendix A).
• 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).
• 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
• 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, see Appendix D and E).
• The patient has a known hypersensitivity to Lymphazurin.
• The patient has participated in another investigational drug study within 30 days of scheduled surgery.
• Melanoma Patients
• The patient has a tumor with a Breslow depth less than 0.75mm.
• Patient has had preoperative chemotherapy, immunotherapy, or radiation therapy.
• 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.
• Patient has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary melanoma.
• 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
• The patient has bilateral primary breast cancers or multiple tumors within their breast.
• Patient has had prior surgical procedures such as breast implants, reduction mammoplasty, or axillary surgery.
• Patient is scheduled for bilateral mastectomy unless for cosmetic reasons and the contraindicated breast will not undergo lymph node mapping.
• Patient has had preoperative radiation therapy to the affected breast or axilla.

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (8)

University of Alabama, Birmingham

Birmingham, Alabama, 35294, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Califonia Pacific Medical Center

San Francisco, California, 94115, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

Location

Breast Care Specialists

Columbus, Ohio, 43081, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• 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

• Sondak VK, King DW, Zager JS, Schneebaum S, Kim J, Leong SP, Faries MB, Averbook BJ, Martinez SR, Puleo CA, Messina JL, Christman L, Wallace AM. Combined analysis of phase III trials evaluating [(9)(9)mTc]tilmanocept and vital blue dye for identification of sentinel lymph nodes in clinically node-negative cutaneous melanoma. Ann Surg Oncol. 2013 Feb;20(2):680-8. doi: 10.1245/s10434-012-2612-z. Epub 2012 Oct 3.

  PMID: 23054107 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

• Simon A Blackburn

  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: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 19, 2010
• Study Start: June 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: June 17, 2013
• Results First Posted: June 3, 2013

Record last verified: 2013-06

Locations

US (8)