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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Melanoma

Thank you

Trial Information

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


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.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Concordance of Blue Dye and Lymphoseek

Outcome Description:

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

Outcome Time Frame:

Surgery after injections of Lymphoseek and blue dye

Safety Issue:

No

Principal Investigator

Richard Orahood, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Navidea Biopharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

NEO3-05

NCT ID:

NCT00671918

Start Date:

April 2008

Completion Date:

July 2009

Related Keywords:

  • Breast Cancer
  • Melanoma
  • breast cancer
  • lymph nodes
  • melanoma
  • surgery
  • Breast Neoplasms
  • Melanoma

Name

Location

Barbara Michna, M.DAlexander City, Alabama  35010
Helen Krontiras, M.D.Birmingham, Alabama  35294
Anne Wallace, M.D.La Jolla, California  92093
Ken Deck, M.D.Laguna Hills, California  92653
Steve Martinez, M.D.Sacramento, California  95817
Mark Faries, M.D.Santa Monica, California  90404
Eli Avisar, M.D.Miami, Florida  33101
Vernon Sondak, M.D.Tampa, Florida  33612
Charles Cox, M.D.Tampa, Florida  33612
Julian Kim, M.D.Cleveland, Ohio  44106
Bruce Averbook, M.DCleveland, Ohio  44109
Stephen Povoski, M.D.Columbus, Ohio  43210
Thomas Frazier, M.D.Bryn Mawr, Pennsylvania  19010
Ned Carp, M.D.Philadelphia, Pennsylvania  19096