Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium

• Status: Terminated
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer).

The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells.

The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborators: Cardinal Health 414, LLC; Navidea Biopharmaceuticals
• Treatments: Dextrans; Technetium Tc 99m Pentetate

Criteria

Inclusion Criteria:

1. The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.

2. The patient has diagnosed cancer of the endometrium.

3. The patient is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.

4. The patient is at least 18 years of age at the time of consent.

5. The patient has an Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2.

6. The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0).

7. If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.

Exclusion Criteria:

1. The patient is pregnant or lactating.

2. 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).

3. The patient has a known hypersensitivity to Lymphazurin or Lymphoseek.

4. The patient has participated in another investigational drug study within 30 days of scheduled surgery.