Trial | NCT02509598  Report issue

Title

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
A Prospective, Open-Label, Multicenter 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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    23
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.
Study Started
Aug 31
2015
Primary Completion
Mar 06
2019
Study Completion
Mar 06
2019
Last Update
Mar 11
2020

Drug Tc99m tilmanocept

A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery

  • Other names: Lymphoseek

Drug Vital Blue Dye (optional)

A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).

  • Other names: Lymphazurin, Isosulfan Blue

Procedure Lymph Node Mapping

Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Tc99m tilmanocept and Vital Blue Dye (optional) Experimental

0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care).

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

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
No Results Posted