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

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509598
• Other study ID #: NAV3-18
• Status: Completed
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: March 6, 2019

Study information

• Verified date: March 2020
• Source: Cardinal Health 414, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 6, 2019
• Est. primary completion date: March 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Rhabdomyosarcoma

Intervention

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
• 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).

Procedure:
• Lymph Node Mapping
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center	Cincinnati	Ohio
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 Specialty Care	Jacksonville	Florida
United States	Nemours Children's Hopsital	Orlando	Florida
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cardinal Health 414, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of lymph nodes identified preoperatively using SPECT or SPECT/CT		1 Day
Secondary	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
Secondary	Agreement of the number of nodes identified by preoperative SPECT or SPECT/CT to intraoperative localization		1 Day
Secondary	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
Secondary	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
Secondary	Number of lymph nodes identified intraoperatively per subject		1 Day
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in subject nodal staging before and after surgery based upon nodes identified		1 Day
Secondary	Subject localization rates	The proportion of subjects with Lymphoseek-identified lymph nodes	1 Day