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



Status:Recruiting
Conditions:Skin Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 17
Updated:12/15/2018
Start Date:August 2015
End Date:June 2021
Contact:LaTosha Eligon
Email:latosha.eligon@cardinalhealth.com
Phone:913.661.3896

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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

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.


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
We found this trial at
6
sites
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Mary Austin, MD
Phone: 713-745-0040
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Jennifer Aldrink, MD
Phone: 614-722-2650
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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Cincinnati, Ohio 45229
Principal Investigator: Roshni Dasgupta, MD, MPH
Phone: 513-803-1971
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Jacksonville, Florida 32207
Principal Investigator: Nicholas Poulos, MD
Phone: 904-697-3465
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Orlando, Florida 32827
Principal Investigator: Tamarah Westmoreland, MD
Phone: 407-650-7175
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Principal Investigator: Marcus Malek, MD
Phone: 412-692-6272
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Pittsburgh, PA
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