Clinical trial NCT02509598: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rhabdomyosarcoma
Melanoma
Lead sponsor: Cardinal Health 414, LLC
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 24
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Average Number of Lymph Nodes Identified Intraoperatively Per Subject
timeFrame: 1 Day
measure: Subject Localization Rates
timeFrame: 1 Day
Secondary outcomes:
measure: Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT
timeFrame: 1 Day
measure: Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT
timeFrame: 1 day
measure: Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject
timeFrame: 1 Day
measure: Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization
timeFrame: 1 Day
measure: Upstaging
timeFrame: 1 Day
measure: Nodal False Negative Rate for Nodes Identified
timeFrame: 1 Day
measure: Nodal Sensitivity
timeFrame: 1 Day
measure: Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases
timeFrame: 1 Day
measure: Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified
timeFrame: 1 Day
measure: Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek
timeFrame: 1 Day
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Specialty Care
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Hopsital
state: Florida
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cardinal Health 414, LLC
name: Michael Blue, MD
role: STUDY_DIRECTOR
References: