Phase 2
N=24
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
Rhabdomyosarcoma · Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT02509598 ↗Enrolled (actual)
24
Serious AEs
13.0%
Results posted
Jun 2024
Primary outcome: Primary: Average Number of Lymph Nodes Identified Intraoperatively Per Subject — 3.30 nodes per subject
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tc99m tilmanocept (Drug); Vital Blue Dye (optional) (Drug); Lymph Node Mapping (Procedure)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Cardinal Health 414, LLC
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Lymph Nodes Identified Intraoperatively Per Subject |
3.30 | — |
| PRIMARY Subject Localization Rates |
22 | — |
| SECONDARY Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT |
21 | — |
| SECONDARY Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT |
20 | — |
| SECONDARY Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject |
2.75 | — |
| SECONDARY Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization |
-0.86 | — |
| SECONDARY Upstaging |
2 | — |
| SECONDARY Nodal False Negative Rate for Nodes Identified |
— | — |
| SECONDARY Nodal Sensitivity |
1.00 | — |
| SECONDARY Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases |
57 | — |
| SECONDARY Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified |
3 | — |
| SECONDARY Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek |
2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02509598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.