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

PHASE3CompletedINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

June 30, 2009

Study Completion Date

July 31, 2009

Conditions
Breast CancerMelanoma
Interventions
DRUG

Lymphoseek

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.

Trial Locations (15)

19010

Thomas Frazier, M.D., Bryn Mawr

19096

Ned Carp, M.D., Philadelphia

33101

Eli Avisar, M.D., Miami

33612

Charles Cox, M.D., Tampa

Vernon Sondak, M.D., Tampa

35010

Barbara Michna, M.D, Alexander City

35294

Helen Krontiras, M.D., Birmingham

43210

Stephen Povoski, M.D., Columbus

44106

Julian Kim, M.D., Cleveland

44109

Bruce Averbook, M.D, Cleveland

64239

Schlomo Schneebaum, M.D., Tel Aviv

90404

Mark Faries, M.D., Santa Monica

92093

Anne Wallace, M.D., La Jolla

92653

Ken Deck, M.D., Laguna Hills

95817

Steve Martinez, M.D., Sacramento

Sponsors
All Listed Sponsors
lead

Navidea Biopharmaceuticals

INDUSTRY