Melanoma Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT02509598

Recruitment Status:

Completed

Sponsor:

Cardinal Health 414, LLC

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There are 6 Locations for this study

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Nemours Children's Specialty Care
Jacksonville Florida, 32207, United States
Nemours Children's Hopsital
Orlando Florida, 32827, United States
Children's Hospital Medical Center
Cincinnati Ohio, 45229, United States
Nationwide Children's Hospital
Columbus Ohio, 43205, United States
Children's Hospital of Pittsburgh
Pittsburgh Pennsylvania, 15224, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

23

Study ID:

NCT02509598

Recruitment Status:

Completed

Sponsor:


Cardinal Health 414, LLC

How clear is this clinincal trial information?

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