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

Cardinal Health 414, LLC6 sites in 1 country24 target enrollmentAugust 2015

ConditionsRhabdomyosarcoma Melanoma

InterventionsTc99m tilmanocept Vital Blue Dye (optional)Lymph Node Mapping

DrugsTc99m tilmanocept Vital Blue Dye (optional)

Overview

Phase: Phase 2
Intervention: Tc99m tilmanocept
Conditions: Rhabdomyosarcoma
Sponsor: Cardinal Health 414, LLC
Enrollment: 24
Locations: 6
Primary Endpoint: Average Number of Lymph Nodes Identified Intraoperatively Per Subject
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

March 6, 2019

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Cardinal Health 414, LLC

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Tc99m tilmanocept and Vital Blue Dye (optional)

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).

Intervention: Tc99m tilmanocept

Tc99m tilmanocept and Vital Blue Dye (optional)

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).

Intervention: Vital Blue Dye (optional)

Tc99m tilmanocept and Vital Blue Dye (optional)

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).

Intervention: Lymph Node Mapping

Outcomes

Primary Outcomes

Average Number of Lymph Nodes Identified Intraoperatively Per Subject

Time Frame: 1 Day

Subject Localization Rates

Time Frame: 1 Day

The proportion of subjects with Lymphoseek-identified lymph nodes

Secondary Outcomes

Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject(1 Day)
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT(1 Day)
Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization(1 Day)
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT(1 day)
Upstaging(1 Day)
Nodal False Negative Rate for Nodes Identified(1 Day)
Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek(1 Day)
Nodal Sensitivity(1 Day)
Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases(1 Day)
Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified(1 Day)