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Sponsored by: |
Neoprobe Corporation |
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Information provided by: | Neoprobe Corporation |
ClinicalTrials.gov Identifier: | NCT00671918 |
Data from this pivotal clinical trial will be used to support a marketing application (i.e., NDA) for Neoprobe's Lymphoseek for use in intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.
Condition | Intervention | Phase |
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Breast Cancer Melanoma |
Drug: Lymphoseek |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Prospective, Open-Label, Multicenter Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Melanoma or Breast Cancer Who Are Undergoing Lymph Node Mapping |
Estimated Enrollment: | 238 |
Study Start Date: | April 2008 |
Study Completion Date: | July 2009 |
Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single Arm, Open Label: Experimental
not applicable
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Drug: Lymphoseek
Breast Cancer: 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 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 into the 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 patients 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.
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In patients with primary melanoma and breast cancer, lymph node status is often a strong predictor of outcome and influences the course of treatment a patient may follow after surgery. In an effort to reduce the morbidity and costs of detection of lymph node metastases, surgical oncologists have developed a method by which the sentinel lymph node (the first node in a draining basin) is identified intraoperatively and removed. This technique, called sentinel node biopsy, has extremely high negative predictive values for melanoma metastases and breast cancer metastases. The two largest trials for melanoma, Morton, et al (2005) and Rossi, et al (2006), reported false negative rates of 6.3% and 14.7%, respectively. Morton, et al (2006), in perhaps the most mature trial reported to date, showed a false negative rate of 3.4% . There is growing evidence that sentinel node biopsy will have a significant impact on the management of melanoma. Sentinel node biopsy also has extremely high negative predictive values for breast cancer metastases; the false-negative rates range from 0% to 9%. There is growing evidence that sentinel node biopsy will have a significant impact on the management of breast cancer. Although the survival and local recurrence studies have yet to be completed, the technique has emerged into common practice.
Lymphatic mapping with a radiopharmaceutical is a nuclear medicine examination which identifies for the surgeon the first lymph node to receive lymphatic flow from the primary tumor site. This node is removed and analyzed for the presence of malignant cells. By locating the lymph node prior to surgery, a small incision can be used to remove the node and a smaller dissection can be employed. The high negative predictive value of the technique seems to provide an accurate staging procedure and may spare patients who are lymph node negative the morbidity of a complete lymph node dissection. Consequently, staging of melanoma by lymph node mapping and biopsy may be equivalent to regional node dissection without the attendant post surgical morbidity.
An ideal lymph node imaging agent would exhibit rapid clearance from the injection site, rapid uptake and high retention within the first draining lymph node, and low uptake by the remaining lymph nodes. The ideal agent would also have low radiation absorption; high biological safety; convenient, rapid, and stable technetium-99m labeling; and biochemical purity.
Lymphoseek (technetium-99m-labeled diethylenetriamine pentaacetic acid-mannosyl-dextran, [Tc-99m]DTPA-mannosyl-dextran) is a radiotracer that accumulates in lymphatic tissue by binding to a mannose-binding protein that resides on the surface of dendritic cells and macrophages. Lymphoseek is a macromolecule consisting of multiple units of DTPA and mannose, each synthetically attached to a 10 kilodalton dextran backbone. The mannose acts as a substrate for the receptor, and the DTPA serves as a chelating agent for labeling with Tc-99m.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Melanoma Patients
Breast Cancer Patients
Exclusion Criteria:
Melanoma Patients
Breast Cancer Patients
United States, Alabama | |
Barbara Michna, M.D | |
Alexander City, Alabama, United States, 35010 | |
Helen Krontiras, M.D. | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
Anne Wallace, M.D. | |
La Jolla, California, United States, 92093 | |
Ken Deck, M.D. | |
Laguna Hills, California, United States, 92653 | |
Mark Faries, M.D. | |
Santa Monica, California, United States, 90404 | |
Steve Martinez, M.D. | |
Sacramento, California, United States, 95817 | |
United States, Florida | |
Vernon Sondak, M.D. | |
Tampa, Florida, United States, 33612 | |
Charles Cox, M.D. | |
Tampa, Florida, United States, 33612 | |
Eli Avisar, M.D. | |
Miami, Florida, United States, 33101 | |
United States, Ohio | |
Stephen Povoski, M.D. | |
Columbus, Ohio, United States, 43210 | |
Julian Kim, M.D. | |
Cleveland, Ohio, United States, 44106 | |
Bruce Averbook, M.D | |
Cleveland, Ohio, United States, 44109 | |
United States, Pennsylvania | |
Ned Carp, M.D. | |
Philadelphia, Pennsylvania, United States, 19096 | |
Thomas Frazier, M.D. | |
Bryn Mawr, Pennsylvania, United States, 19010 | |
Israel | |
Schlomo Schneebaum, M.D. | |
Tel Aviv, Israel, 64239 |
Study Director: | Richard Orahood, M.D. | Neoprobe Corporation |
Responsible Party: | Neoprobe Corporation ( Simon Blackburn; Director, Clinical Research ) |
Study ID Numbers: | NEO3-05 |
Study First Received: | April 30, 2008 |
Last Updated: | August 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00671918 History of Changes |
Health Authority: | United States: Food and Drug Administration |
breast cancer lymph nodes melanoma surgery |
Neuroectodermal Tumors Skin Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Breast Neoplasms Nevus Breast Diseases Neuroendocrine Tumors Melanoma |
Neuroectodermal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Skin Diseases Neoplasms, Germ Cell and Embryonal |
Neoplasms, Nerve Tissue Breast Neoplasms Nevi and Melanomas Breast Diseases Neuroendocrine Tumors Melanoma |