RhabdomyosarcomaPhase 2NCT02509598
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 Phase 2 study testing Tc99m tilmanocept, Vital Blue Dye (optional) and Lymph Node Mapping in people with Rhabdomyosarcoma and Melanoma, run by Cardinal Health 414, LLC at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Rhabdomyosarcoma, Melanoma
- What is being tested?
- Tc99m tilmanocept, Vital Blue Dye (optional) and Lymph Node Mapping
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2015to 6 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Nemours Children's Specialty Care
Jacksonville, Florida, 32207
Nemours Children's Hopsital
Orlando, Florida, 32827
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
About this study
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
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.
- Conditions
- Rhabdomyosarcoma, Melanoma
- Being tested
- Tc99m tilmanocept, Vital Blue Dye (optional), Lymph Node Mapping
- Medical subject headings
- Rhabdomyosarcoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99m tilmanoceptDrug
Also called Lymphoseek
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)Drug
Also called Lymphazurin, Isosulfan Blue
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).
Lymph Node MappingProcedure or surgery
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection
| Study group | Role | What they receive |
|---|---|---|
| Tc99m tilmanocept and Vital Blue Dye (optional) | Experimental | 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). Receives: Drug: Tc99m tilmanocept; Drug: Vital Blue Dye (optional); Procedure: Lymph Node Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Number of Lymph Nodes Identified Intraoperatively Per Subject
Measured: 1 Day
Subject Localization Rates
The proportion of subjects with Lymphoseek-identified lymph nodes
Measured: 1 Day
Secondary outcomes (10)
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT
Measured: 1 Day
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT
Measured: 1 day
Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject
Measured: 1 Day
Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization
Average difference in number of LNs identified preoperatively with SPECT/CR and number of LNs identified intraoperatively per subject
Measured: 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)
Measured: 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. Population is all subjects with pathology-positive nodes. False negative rate represents the failure rate of the mapping agent to identify sentinel lymph nodes.
Measured: 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. Population is all subjects with pathology-positive nodes. Sensitivity rate represents the success rate of the mapping agent to identify sentinel lymph nodes.
Measured: 1 Day
Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases
Number of nodes whose local and central pathology results agree divided by the number of nodes with nonmissing local and central pathology results
Measured: 1 Day
Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified
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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion6 Mar 2019
- Study completion6 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhabdomyosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Health 414, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Blue, MD, Study director, Cardinal Health 414, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509598
- Sponsor's protocol ID
- NAV3-18
- Status last verified
- Jun 2024
- First submitted
- 24 Jul 2015
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02509598
- Acronym / sponsor ID
- NAV3-18
- Conditions
- Rhabdomyosarcoma, Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cardinal Health 414, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- 6 Mar 2019 (actual)
- Study completion
- 6 Mar 2019 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc99m tilmanocept and Vital Blue Dye (optional) | Experimental | Drug: Tc99m tilmanocept, Drug: Vital Blue Dye (optional), Procedure: Lymph Node Mapping0.5 mCi, 50 ug of Tc99m tilmanocept single administration. Optionally, 1-3 mL of vital blue dye, single administration (per institution's standard of care). |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc99m tilmanoceptAlso: LymphoseekA single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery | Drug | Tc99m tilmanocept and Vital Blue Dye (optional) |
| Vital Blue Dye (optional)Also: Lymphazurin, Isosulfan BlueA 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). | Drug | Tc99m tilmanocept and Vital Blue Dye (optional) |
| Lymph Node MappingIntraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection | Procedure or surgery | Tc99m tilmanocept and Vital Blue Dye (optional) |
Primary outcome
Average Number of Lymph Nodes Identified Intraoperatively Per Subject
Time frame: 1 Day
Subject Localization Rates
Time frame: 1 Day
The proportion of subjects with Lymphoseek-identified lymph nodes
10 secondary outcomes
Proportion of Subjects Who Underwent Preoperative SPECT or SPECT/CT
Time frame: 1 Day
Proportion of Subjects With a Lymph Node Identified Preoperatively Using SPECT or SPECT/CT
Time frame: 1 day
Average Number of Lymph Nodes Identified Preoperatively Using SPECT or SPECT/CT Per Subject
Time frame: 1 Day
Agreement of the Number of Nodes Identified by Preoperative SPECT or SPECT/CT to Intraoperative Localization
Time frame: 1 Day
Upstaging
Time frame: 1 Day
Nodal False Negative Rate for Nodes Identified
Time frame: 1 Day
Nodal Sensitivity
Time frame: 1 Day
Nodal Agreement of Central Pathology Assessment With Local Pathology Assessment of the Excised Lymph Node(s) to Confirm the Presence/Absence of Tumor Metastases
Time frame: 1 Day
Change in Subject Nodal Staging Before and After Surgery Based Upon Nodes Identified
Time frame: 1 Day
Number of Changes in Postsurgical Treatment Plan in Relation to Nodes Identified by Lymphoseek
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Blue, MD study director
Cardinal Health 414, LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc99m tilmanocept, Vital Blue Dye (optional) and Lymph Node Mapping in people with Rhabdomyosarcoma and Melanoma, run by Cardinal Health 414, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Number of Lymph Nodes Identified Intraoperatively Per Subject (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.