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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Rhabdomyosarcoma
• Intervention / Treatment: Drug: Tc99m tilmanocept; Drug: Vital Blue Dye (optional); Procedure: Lymph Node Mapping

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Nemours Children's Specialty Care
    • Orlando, Florida, United States, 32827
      • Nemours Children's Hopsital
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Children's Hospital of Pittsburgh
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Md Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tc99m tilmanocept and 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).

Drug: Tc99m tilmanocept; A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery; Other Names: Lymphoseek; Drug: Vital Blue Dye (optional); 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).; Other Names: Lymphazurin; Isosulfan Blue; Procedure: Lymph Node Mapping; Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cardinal Health 414, LLC
• Investigators: Study Director: Michael Blue, MD, Cardinal Health 414, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 6, 2019
• Study Completion (Actual): March 6, 2019

Study Registration Dates

• First Submitted: July 24, 2015
• First Submitted That Met QC Criteria: July 24, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Actual): March 11, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Sarcoma; Neoplasms, Muscle Tissue; Myosarcoma; Melanoma; Rhabdomyosarcoma
• Other Study ID Numbers: NAV3-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO