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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhabdomyosarcoma, Melanoma

Intervention / Treatment
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* Drug: Tc99m tilmanocept
* Drug: Vital Blue Dye (optional)
* Procedure: Lymph Node Mapping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tc99m tilmanocept and Vital Blue Dye (optional)<br>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). | Drug: Tc99m tilmanocept<br>* A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery<br>* Other names: Lymphoseek;Drug: Vital Blue Dye (optional)<br>* A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).<br>* Other names: Isosulfan Blue;Procedure: Lymph Node Mapping<br>* Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping | Evaluation of safety and tolerability of Lymphoseek | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in vital signs | Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each vital sign parameter by time point, for each tumor type and overall. | 14 Days | 
| Changes in laboratory parameters | Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each quantitative laboratory parameter by time point, for each tumor type and overall. | 14 Days | 
| Changes in ECG parameters | Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each ECG parameter by time point, for each tumor type and overall. | 14 Days | 
| Number of lymph nodes identified preoperatively using SPECT or SPECT/CT |  | 1 Day | 
| Proportion of subjects who underwent preoperative SPECT or SPECT/CT and proportion of subjects with a lymph node identified preoperatively using SPECT or SPECT/CT |  | 1 Day | 
| Agreement of the number of nodes identified by preoperative SPECT or SPECT/CT to intraoperative localization |  | 1 Day | 
| Subject and 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 changes in postsurgical treatment plan in relation to nodes identified by Lymphoseek | Changes to postsurgical treatment plan will be compared to baseline treatment plan. | 1 Day | 
| Number of lymph nodes identified intraoperatively per subject |  | 1 Day | 
| Nodal false negative rate for nodes identified | 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. | 1 Day | 
| Nodal sensitivity | 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. | 1 Day | 
| Upstaging | 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) | 1 Day | 
| Change in subject nodal staging before and after surgery based upon nodes identified |  | 1 Day | 
| Subject localization rates | The proportion of subjects with Lymphoseek-identified lymph nodes | 1 Day |