A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping

Completed · Phase 2

Conditions studied: Rhabdomyosarcoma, Melanoma

In brief

Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.

Key facts

Study ID

NCT02509598

Run by

Cardinal Health 414, LLC

People needed

24

Starts

2015-08-01

Expected to finish

2019-03-06

Last updated by the study team

2024-06-28

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted
• Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate
• The subject is clinically node negative (cN0) at the time of screening
• Age < 18 years
• Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study
• Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study

You may not qualify if…

• The subject has had preoperative radiation therapy
• Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure
• Has a known allergy to dextran or VBD (if intended to be used)
• Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator
• Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical

Where it is running

• Nemours Children's Specialty Care — Jacksonville, Florida, United States
• Nemours Children's Hopsital — Orlando, Florida, United States
• Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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