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

Cardinal Health

Status and phase: Completed; Phase 2

Conditions: Melanoma; Rhabdomyosarcoma

Treatments: Drug: Tc99m tilmanocept; Procedure: Lymph Node Mapping; Drug: Vital Blue Dye (optional)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509598

NAV3-18

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Tc99m tilmanocept and Vital Blue Dye (optional)

Experimental group

Description:

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).

Treatment:

Drug: Vital Blue Dye (optional)

Procedure: Lymph Node Mapping

Drug: Tc99m tilmanocept