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
- Conditions
- RhabdomyosarcomaMelanoma
- Interventions
- Registration Number
- NCT02509598
- Lead Sponsor
- Cardinal Health 414, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tc99m tilmanocept and Vital Blue Dye (optional) 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). Tc99m tilmanocept and Vital Blue Dye (optional) Lymph Node Mapping 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). Tc99m tilmanocept and Vital Blue Dye (optional) Tc99m tilmanocept 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).
- Primary Outcome Measures
Name Time Method Average Number of Lymph Nodes Identified Intraoperatively Per Subject 1 Day Subject Localization Rates 1 Day The proportion of subjects with Lymphoseek-identified lymph nodes
- Secondary Outcome Measures
Name Time Method Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject 1 Day Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT 1 Day Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization 1 Day Average difference in number of LNs identified preoperatively with SPECT/CR and number of LNs identified intraoperatively per subject
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT 1 day Upstaging 1 Day The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method)
Nodal False Negative Rate for Nodes Identified 1 Day The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. False negative rate represents the failure rate of the mapping agent to identify sentinel lymph nodes.
Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek 1 Day Changes to postsurgical treatment plan will be compared to baseline treatment plan.
Nodal Sensitivity 1 Day The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. Population is all subjects with pathology-positive nodes. Sensitivity rate represents the success rate of the mapping agent to identify sentinel lymph nodes.
Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases 1 Day Number of nodes whose local and central pathology results agree divided by the number of nodes with nonmissing local and central pathology results
Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified 1 Day Change in subject nodal staging was assessed via shift tables to show the number of subjects with each combination of presurgery and postsurgery nodal staging. Presurgery staging was based on standard-of-care clinical assessment. Postsurgery staging was based on the pathology results of the nodes identified.
Trial Locations
- Locations (6)
Children's Hospital of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Nemours Children's Specialty Care
🇺🇸Jacksonville, Florida, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Nemours Children's Hopsital
🇺🇸Orlando, Florida, United States
Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States