Trial · NCT02452554

Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma

NCT02452554, Phase 2, Completed, Children's Oncology Group; results first posted 2019-08-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma. Trials, record NCT02452554. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02452554

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
NCT number: NCT02452554
Status: Completed
Phases: Phase 2
Enrollment: 62 participants, actual
Lead sponsor: Children's Oncology Group
Conditions: Pleuropulmonary Blastoma, Recurrent Malignant Peripheral Nerve Sheath Tumor, Recurrent Neuroblastoma, Recurrent Rhabdomyosarcoma, Recurrent Synovial Sarcoma, Wilms Tumor
Interventions: Laboratory Biomarker Analysis, Lorvotuzumab Mertansine, Pharmacological Study
First posted: 2015-05-22
Last updated: 2022-01-13
Results first posted: 2019-08-29

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 18 weeks (6 courses)	The best response of disease will be examined separately in each stratum. A responder is defined as a patient who achieves a best response of partial response or complete response on the study. Response rates will be calculated as the percent of evaluable patients who are responders, and Clopper-Pearson confidence intervals will be constructed.
Primary	Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Up to 12 months (17 courses)	Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade for toxicities with Possible, Probable, or Definite attribution to the study drug. Tables will summarize incidence by cycle.
Other	Pharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine	Pre-treatment, end of infusion, and 2, 6, 24, 48, and 96 hours after end of infusion on day 1 of course 1, and pre-treatment, end of infusion, and 2 and 6 hours after end of infusion on day 8 of course 1	A descriptive analysis of PK parameters of lorvotuzumab mertansine will be performed to define systemic exposure, drug clearance, and other pharmacokinetic parameters. The PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). Analyses will be descriptive and exploratory and hypotheses generating in nature.
Other	CD56 Expression	Day 1 and 8 of course 1 prior to lorvotuzumab mertansine	The association between CD56+ expression and response will be evaluated using the exact conditional test of proportions (Fisher?s Exact test). Analyses will be descriptive and exploratory and hypotheses generating in nature.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Up to 18 weeks (6 courses)	2 participants were excluded from analysis; 1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.	Percent of participants	NUMBER
PRIMARY	Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Up to 12 months (17 courses)	203 treatment-cycles were reported for the analysis. 2 participants were excluded from analysis;1 participant never received treatment and 1 participant was ineligible, also never receiving treatment.	Treatment cycles	NUMBER
OTHER_PRE_SPECIFIED	Pharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine	Pre-treatment, end of infusion, and 2, 6, 24, 48, and 96 hours after end of infusion on day 1 of course 1, and pre-treatment, end of infusion, and 2 and 6 hours after end of infusion on day 8 of course 1
OTHER_PRE_SPECIFIED	CD56 Expression	Day 1 and 8 of course 1 prior to lorvotuzumab mertansine

Source ClinicalTrials.gov

Results by group78

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 1: Wims Tumor		0.00	95% Confidence Interval 0.00 to 20.59	Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 2: Rhabdomyosarcoma		6.25	95% Confidence Interval 0.16 to 30.23	Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 3: Neuroblastoma		0.00	95% Confidence Interval 0.00 to 26.46	Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 4: Pleuropulmonary Blastoma		0.00	95% Confidence Interval 0.00 to 97.50	Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 5: Malignant Peripheral Nerve Sheath Tumor		0.00	95% Confidence Interval 0.00 to 52.18	Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	Stratum 6: Synovial Sarcoma		0.00	95% Confidence Interval 0.00 to 30.85	Percent of participants
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Treatment (Lorvotuzumab Mertansine)	Anemia: Grade 2	0		Treatment cycles
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Treatment (Lorvotuzumab Mertansine)	Anemia: Grade 3	2		Treatment cycles
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Treatment (Lorvotuzumab Mertansine)	Anemia: Grade 4	0		Treatment cycles
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	Treatment (Lorvotuzumab Mertansine)	Anemia: Grade 5	0		Treatment cycles

1 to 10 of 78Source ClinicalTrials.gov

See all 78 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Stratum 1: Wims Tumor	17
Overall Study	STARTED	Stratum 2: Rhabdomyosarcoma	17
Overall Study	STARTED	Stratum 3: Neuroblastoma	12
Overall Study	STARTED	Stratum 4: Pleuropulmonary Blastoma	1
Overall Study	STARTED	Stratum 5: Malignant Peripheral Nerve Sheath Tumor	5
Overall Study	STARTED	Stratum 6: Synovial Sarcoma	10
Overall Study	COMPLETED	Stratum 1: Wims Tumor	0
Overall Study	COMPLETED	Stratum 2: Rhabdomyosarcoma	0
Overall Study	COMPLETED	Stratum 3: Neuroblastoma	1
Overall Study	COMPLETED	Stratum 4: Pleuropulmonary Blastoma	0

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events306

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain	Gastrointestinal disorders	Stratum 1: Wims Tumor	0	16
other	Abdominal pain	Gastrointestinal disorders	Stratum 2: Rhabdomyosarcoma	0	16
other	Abdominal pain	Gastrointestinal disorders	Stratum 3: Neuroblastoma	0	12
other	Abdominal pain	Gastrointestinal disorders	Stratum 4: Pleuropulmonary Blastoma	1	1
other	Abdominal pain	Gastrointestinal disorders	Stratum 5: Malignant Peripheral Nerve Sheath Tumor	0	5
other	Abdominal pain	Gastrointestinal disorders	Stratum 6: Synovial Sarcoma	0	10
other	Alanine aminotransferase increased	Investigations	Stratum 1: Wims Tumor	0	16
other	Alanine aminotransferase increased	Investigations	Stratum 2: Rhabdomyosarcoma	0	16
other	Alanine aminotransferase increased	Investigations	Stratum 3: Neuroblastoma	1	12
other	Alanine aminotransferase increased	Investigations	Stratum 4: Pleuropulmonary Blastoma	0	1

1 to 10 of 306Source ClinicalTrials.gov

See all 306 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Stratum 1: Wims Tumor	10	17
Total, all-cause mortality	Stratum 2: Rhabdomyosarcoma	11	16
Total, all-cause mortality	Stratum 3: Neuroblastoma	4	12
Total, all-cause mortality	Stratum 4: Pleuropulmonary Blastoma	1	1
Total, all-cause mortality	Stratum 5: Malignant Peripheral Nerve Sheath Tumor	1	5
Total, all-cause mortality	Stratum 6: Synovial Sarcoma	2	10
Total, other adverse events	Stratum 1: Wims Tumor	5	16
Total, other adverse events	Stratum 2: Rhabdomyosarcoma	4	16
Total, other adverse events	Stratum 3: Neuroblastoma	4	12
Total, other adverse events	Stratum 4: Pleuropulmonary Blastoma	1	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180886	COG NCTN Network Group Operations Center	Hawkins, Douglas S.	COG RESEARCH FOUNDATION, LLC	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02452554

GET https://conductscience.org/api/trials/v1/NCT02452554/results?page=2

API reference For AI assistants