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

NCT ID: NCT02509598

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2019-03-06

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.

Conditions

Rhabdomyosarcoma; Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Tc99m tilmanocept

Intervention Type: DRUG

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

Vital Blue Dye (optional)

Intervention Type: DRUG

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).

Lymph Node Mapping

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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).

Intervention Type: DRUG

Lymph Node Mapping

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

Intervention Type: PROCEDURE

Other Intervention Names

Lymphoseek; Lymphazurin; Isosulfan Blue

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cardinal Health 414, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Blue, MD

Role: STUDY_DIRECTOR

Cardinal Health 414, LLC

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NAV3-18

Identifier Type: -

Identifier Source: org_study_id