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 | 
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.
			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
	
			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
	
			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
	
			
					Pittsburgh, Pennsylvania 15213
Principal Investigator: Marcus Malek, MD
			
						
										Phone: 412-692-6272
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