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

NCT02589366 | Terminated Phase 1 DMC

• 1 other identifier: HRPP #141163
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endometrial Cancer

Keywords

Lymphoseek; endometrial cancer; sentinel lymph node; lymph node dissection

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Adverse events experienced by the participants and radiation absorbed dose of injected Lymphoseek.

  0-15 days Postoperatively

Secondary Outcomes (2)

• Number of Lymphoseek positive lymph nodes detected preoperatively and intraoperatively.

  2 days

• Number of lymph nodes identified intraoperatively as assessed by visualization and handheld gamma probe detection

  2 days

Study Arms (1)

Lymphoseek plus Vital Blue Dye

EXPERIMENTAL

Lymphoseek plus Vital Blue Dye: Single dose of 50 µg Lymphoseek radiolabeled with 75 MBq Tc 99m injected pre-operatively followed by next day intra-operative administration of vital blue dye.

Drug: Lymphoseek plus Vital Blue Dye

Interventions

Lymphoseek plus Vital Blue Dye DRUG

intrapatient comparison of Lymphoseek with Vital Blue Dye in detecting lymph node metastases

Also known as: Technetium TC 99M, Tilmanocept, Lymphazurin

Lymphoseek plus Vital Blue Dye

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.
• The patient has diagnosed cancer of the endometrium.
• The patient is a candidate for surgical intervention, with lymph node dissection 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 Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2.
• The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0).
• 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.

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).
• The patient has a known hypersensitivity to Lymphazurin or Lymphoseek.
• The patient has participated in another investigational drug study within 30 days of scheduled surgery.

Sponsors & Collaborators

• University of California, San Diego: lead
• Cardinal Health 414, LLC: collaborator

Study Sites (1)

University of California, San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; Technetium; iso-sulfan blue

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Transition Elements; Radioisotopes; Isotopes; Metals

Study Officials

• Michael McHale, MD, FACS

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician Diplomate

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 28, 2015
• Study Start: November 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)