ClinicalTrials.gg
CompletedNCT02452554Updated Jan 13, 2022Results posted

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

A Phase 2 interventional study of Laboratory Biomarker Analysis and Lorvotuzumab Mertansine in Pleuropulmonary Blastoma, Recurrent Malignant Peripheral Nerve Sheath Tumor and Recurrent Neuroblastoma, sponsored by Children's Oncology Group. Completed at 69 sites in United States. Open to participants aged 12 Months to 30 Years. Per ClinicalTrials.gov, last updated 2022-01-13.

Sponsored by Children's Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
12 Months to 30 Years
Sex
All
01

Study summary

This phase II trial studies how well lorvotuzumab mertansine works in treating younger patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab mertansine, are created by attaching an antibody (protein used by the body?s immune system to fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize tumor cells so the anti-cancer drug can kill them.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the efficacy of IMGN901 (lorvotuzumab mertansine) in Wilms tumor, rhabdomyosarcoma, neuroblastoma and other cluster of differentiation (CD)56-expressing tumors such as pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST) and synovial sarcoma.

II. To determine the tolerability of the adult recommended phase 2 dose (RP2D) of IMGN901 administered as an intravenous infusion, administered on days 1 and 8 of a 21-day cycle, to children with refractory Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma, MPNST, or synovial sarcoma.

III. To define and describe the toxicities of IMGN901 administered on this schedule.

EXPLORATORY OBJECTIVES:

I. To correlate tumor response with tumor CD56+ expression. II. To characterize the pharmacokinetics of IMGN901 in children with refractory cancer, including an assessment of impact on circulating CD56+ peripheral blood cells.

OUTLINE:

Patients receive lorvotuzumab mertansine intravenously (IV) over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

02

Conditions studied

  • Pleuropulmonary Blastoma
  • Recurrent Malignant Peripheral Nerve Sheath Tumor
  • Recurrent Neuroblastoma
  • Recurrent Rhabdomyosarcoma
  • Recurrent Synovial Sarcoma
  • Wilms Tumor
03

In context

Neurofibrosarcoma

71 studies on the registry are indexed under Neurofibrosarcoma; 22 are open to participants now.

This study's enrollment of 62 is above the median of 44 across 59 interventional studies indexed under Neurofibrosarcoma.

Browse Neurofibrosarcoma studies →

Lead sponsor

Children's Oncology Group is the lead sponsor of 447 studies on the registry; 35 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Months to 30 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse

    • Primary strata

      • Wilms tumor
      • Rhabdomyosarcoma
      • Neuroblastoma
    • Secondary strata: miscellaneous CD56-expressing tumors:

      • Pleuropulmonary blastoma
      • Malignant peripheral nerve sheath tumor (MPNST)
      • Synovial sarcoma
  • Patients must have radiographically measurable disease (with the exception of those with neuroblastoma)

    • Measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm)
    • Note: the following do not qualify as measurable disease:

      • Malignant fluid collections (e.g., ascites, pleural effusions)
      • Bone marrow infiltration except that detected by metaiodobenzylguanidine (MIBG) scan for neuroblastoma
      • Lesions only detected by nuclear medicine studies (e.g., bone, gallium or positron emission tomography [PET] scans) except as noted in patients with neuroblastoma who do not have measurable disease but have MIBG-avid evaluable disease
      • Elevated tumor markers in plasma or cerebrospinal fluid (CSF)
      • Previously radiated lesions that have not demonstrated clear progression post radiation
      • Leptomeningeal lesions that do not meet the measurements noted above
  • Patients with neuroblastoma who do not have measurable disease but have MIBG-avid evaluable disease are eligible
  • Patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use Karnofsky for patients > 16 years of age and Lansky for patients =\< 16 years of age; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
  • Patients must have received standard treatment appropriate for their tumor type

    • Myelosuppressive chemotherapy: patients with solid tumors must not have received myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6 weeks if prior nitrosourea)
    • Hematopoietic growth factors: at least 14 days must have elapsed after receiving pegfilgrastim and least 7 days must have elapsed since the completion of therapy with a non-pegylated growth factor
    • Biologic (anti-neoplastic agent): at least 7 days must have elapsed since completion of therapy with a biologic agent; for agents that have known adverse events occurring beyond 7 days after administration, this period prior to enrollment must be extended beyond the time during which adverse events are known to occur
    • Monoclonal antibodies: at least 3 half-lives must have elapsed since prior therapy that included a monoclonal antibody
    • Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since treatment with therapeutic doses of MIBG; >= 3 months must have elapsed if prior craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other substantial bone marrow irradiation was given
    • Stem cell transplant or rescue without TBI: no evidence of active graft vs. host disease and >= 2 months must have elapsed since transplant
  • For patients with solid tumors without bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/uL
  • For patients with solid tumors without bone marrow involvement: platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
  • For patients with solid tumors and known bone marrow metastatic disease: peripheral absolute neutrophil count (ANC) >= 750/uL
  • For patients with solid tumors and known bone marrow metastatic disease: platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:

    • Age 1 to \< 2 years: maximum serum creatinine: 0.6 mg/dL in males and females
    • Age 2 to \< 6 years: maximum serum creatinine: 0.8 mg/dL in males and females
    • Age 6 to \< 10 years: maximum serum creatinine: 1 mg/dL in males and females
    • Age 10 to \< 13 years: maximum serum creatinine: 1.2 mg/dL in males and females
    • Age 13 to \< 16 years: maximum serum creatinine: 1.5 mg/dL in males and 1.4 mg/dL in females
    • Age >= 16 years: maximum serum creatinine: 1.7 mg/dL in males and 1.4 mg/dL in females
  • Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =\< 110 U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)
  • Serum albumin >= 2 g/dL
  • Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
  • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion criteria

Exclusion Criteria:

  • Patients who are pregnant or breast-feeding are not eligible for this study; negative pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy and for 4 weeks after the last dose of study therapy; breastfeeding women are excluded
  • Concomitant medications

    • Corticosteroids: patients requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for the 7 days prior to enrollment are not eligible
    • Patients who have received previous treatment with IMGN901 are not eligible
    • Investigational drugs: patients who are currently receiving another investigational drug are not eligible
    • Anti-cancer agents: patients who are currently receiving other anti-cancer agents are not eligible
    • Anti-graft-versus-host disease (GVHD) or agents to prevent organ rejection post-transplant: patients who are receiving cyclosporine, tacrolimus or other agents to prevent either graft-versus-host disease post bone marrow transplant or organ rejection post-transplant are not eligible for this trial
  • Patients who have a CNS toxicity > grade 2 are not eligible
  • Patients must not have known active central nervous system (CNS) metastases; patients with known central nervous system metastases are excluded unless treated surgically or with radiotherapy, and stable with no recurrent lesions for at least 6 months
  • Patients who have baseline peripheral neuropathy >= grade 2 are not eligible
  • Patients who have an uncontrolled infection are not eligible
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    Treatment (lorvotuzumab mertansine)

    Patients receive lorvotuzumab mertansine IV over 1-1.5 hours on days 1 and 8. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

    Other: Laboratory Biomarker Analysis · Biological: Lorvotuzumab Mertansine · Other: Pharmacological Study

Interventions

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • Given IV

    Also known as: Anti-Human NCAM-1 Monoclonal Antibody N901, BB-10901, huN901-DM1, IMGN901

  • OtherPharmacological Study

    Correlative studies

06

What researchers measure

Primary outcomes

  1. Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1

    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.

    Time frame: Up to 18 weeks (6 courses)

  2. Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0

    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.

    Time frame: Up to 12 months (17 courses)

Other outcomes

  1. Pharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine

    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.

    Time frame: 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

  2. CD56 Expression

    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.

    Time frame: Day 1 and 8 of course 1 prior to lorvotuzumab mertansine

07

Results

Posted Aug 29, 2019

Participant flow

Each of 6 disease strata enrolled up to 16 patients who were evaluable for the primary response criteria.

Participant flow — Overall Study
MilestoneStratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial Sarcoma
Started1717121510
Completed001001
Not completed171711159
Withdrew: Death210000
Withdrew: Lack of efficacy13149158
Withdrew: Physician decision010000
Withdrew: Withdrawal by subject102001
Withdrew: Ineligible010000
Withdrew: Never received treatment100000

Outcome measures

PrimaryObjective Response by Response Evaluation Criteria in Solid Tumors Version 1.1

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.

Time frame:
Up to 18 weeks (6 courses)
Reported as:
Number · Percent of participants
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1
Percent of participantsStratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial Sarcoma
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.10.00 (0.00 to 20.59)6.25 (0.16 to 30.23)0.00 (0.00 to 26.46)0.00 (0.00 to 97.50)0.00 (0.00 to 52.18)0.00 (0.00 to 30.85)
PrimaryIncidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0

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.

Time frame:
Up to 12 months (17 courses)
Reported as:
Number · Treatment cycles
Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0
Treatment cyclesTreatment (Lorvotuzumab Mertansine)
Anemia: Grade 20
Anemia: Grade 32
Anemia: Grade 40
Anemia: Grade 50
Colonic fistula: Grade 20
Colonic fistula: Grade 30
Colonic fistula: Grade 41
Colonic fistula: Grade 50
Colonic perforation: Grade 20
Colonic perforation: Grade 30
Colonic perforation: Grade 40
Colonic perforation: Grade 51
Dental caries: Grade 20
Dental caries: Grade 31
Dental caries: Grade 40
Dental caries: Grade 50
Nausea: Grade 20
Nausea: Grade 31
Nausea: Grade 40
Nausea: Grade 50
Vomiting: Grade 21
Vomiting: Grade 31
Vomiting: Grade 40
Vomiting: Grade 50
Tooth infection: Grade 20
Tooth infection: Grade 31
Tooth infection: Grade 40
Tooth infection: Grade 50
Alanine aminotransferase increased: Grade 20
Alanine aminotransferase increased: Grade 33
Alanine aminotransferase increased: Grade 40
Alanine aminotransferase increased: Grade 50
Aspartate aminotransferase increased: Grade 20
Aspartate aminotransferase increased: Grade 31
Aspartate aminotransferase increased: Grade 40
Aspartate aminotransferase increased: Grade 50
Lymphocyte count decreased: Grade 20
Lymphocyte count decreased: Grade 32
Lymphocyte count decreased: Grade 40
Lymphocyte count decreased: Grade 50
Hyperglycemia: Grade 20
Hyperglycemia: Grade 31
Hyperglycemia: Grade 40
Hyperglycemia: Grade 50
Hyperuricemia: Grade 20
Hyperuricemia: Grade 31
Hyperuricemia: Grade 40
Hyperuricemia: Grade 50
Hypokalemia: Grade 20
Hypokalemia: Grade 31
Hypokalemia: Grade 40
Hypokalemia: Grade 50
Hypophosphatemia: Grade 20
Hypophosphatemia: Grade 31
Hypophosphatemia: Grade 40
Hypophosphatemia: Grade 50
Headache: Grade 21
Headache: Grade 30
Headache: Grade 40
Headache: Grade 50
Peripheral motor neuropathy: Grade 20
Peripheral motor neuropathy: Grade 31
Peripheral motor neuropathy: Grade 40
Peripheral motor neuropathy: Grade 50
Peripheral sensory neuropathy: Grade 20
Peripheral sensory neuropathy: Grade 31
Peripheral sensory neuropathy: Grade 40
Peripheral sensory neuropathy: Grade 50
All Reportable AEs: Grade 22
All Reportable AEs: Grade 318
All Reportable AEs: Grade 41
All Reportable AEs: Grade 51
Other pre-specifiedPharmacokinetic (PK) Parameters of Lorvotuzumab Mertansine

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.

Time frame:
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

Results for this outcome have not been posted.

Other pre-specifiedCD56 Expression

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.

Time frame:
Day 1 and 8 of course 1 prior to lorvotuzumab mertansine

Results for this outcome have not been posted.

Adverse events

Collected over While patients were on Protocol Therapy: Up to 17, 28-day cycles. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Stratum 1: Wims Tumor10/17 (58.8%)7/16 (43.8%)5/16 (31.3%)
Stratum 2: Rhabdomyosarcoma11/16 (68.8%)8/16 (50%)4/16 (25%)
Stratum 3: Neuroblastoma4/12 (33.3%)1/12 (8.3%)4/12 (33.3%)
Stratum 4: Pleuropulmonary Blastoma1/1 (100%)0/1 (0%)1/1 (100%)
Stratum 5: Malignant Peripheral Nerve Sheath Tumor1/5 (20%)0/5 (0%)1/5 (20%)
Stratum 6: Synovial Sarcoma2/10 (20%)3/10 (30%)4/10 (40%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventStratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial Sarcoma
VomitingGastrointestinal disorders0/161/160/120/10/52/10
Pleural effusionRespiratory, thoracic and mediastinal disorders3/160/160/120/10/51/10
Abdominal painGastrointestinal disorders2/162/160/120/10/50/10
DehydrationMetabolism and nutrition disorders0/162/160/120/10/50/10
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specifyNeoplasms benign, malignant and unspecified (incl cysts and polyps)2/162/160/120/10/50/10
Alanine aminotransferase increasedInvestigations1/160/160/120/10/51/10
HeadacheNervous system disorders0/160/160/120/10/51/10
NauseaGastrointestinal disorders0/160/160/120/10/51/10
Dental cariesGastrointestinal disorders0/160/161/120/10/50/10
Tooth infectionInfections and infestations0/160/161/120/10/50/10
Most frequent other events
Showing 10 of 25
Most frequent other events
EventStratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial Sarcoma
Abdominal painGastrointestinal disorders0/160/160/121/10/50/10
AtelectasisRespiratory, thoracic and mediastinal disorders0/160/160/121/10/50/10
DehydrationMetabolism and nutrition disorders1/160/160/121/10/50/10
DyspneaRespiratory, thoracic and mediastinal disorders0/161/160/121/10/50/10
HyponatremiaMetabolism and nutrition disorders0/160/160/121/10/50/10
Pain in extremityMusculoskeletal and connective tissue disorders0/160/160/121/10/50/10
Lymphocyte count decreasedInvestigations0/163/160/120/10/52/10
Weight lossInvestigations0/160/160/120/11/50/10
AnemiaBlood and lymphatic system disorders2/160/161/120/10/50/10
FeverGeneral disorders0/160/160/120/10/51/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Stratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial SarcomaTotal
<=18 years1371215644
Between 18 and 65 years410000418
>=65 years0000000
Age, Continuous
Age, Continuous(Years)Stratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial SarcomaTotal
Mean12.61 ± 6.4818.43 ± 5.287.78 ± 1.943.69 ± NA12.96 ± 4.2917.37 ± 4.5913.2 ± 6.37
Sex: Female, Male
Sex: Female, Male(Participants)Stratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial SarcomaTotal
Female58314627
Male129901435
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Stratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial SarcomaTotal
Hispanic or Latino2310118
Not Hispanic or Latino13141014951
Unknown or Not Reported2010003
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Stratum 1: Wims TumorStratum 2: RhabdomyosarcomaStratum 3: NeuroblastomaStratum 4: Pleuropulmonary BlastomaStratum 5: Malignant Peripheral Nerve Sheath TumorStratum 6: Synovial SarcomaTotal
American Indian or Alaska Native0000000
Asian1000102
Native Hawaiian or Other Pacific Islander0000000
Black or African American2310129
White10141013543
More than one race0000000
Unknown or Not Reported4010038
08

Study locations

69 sites
  • Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
  • Arkansas Children's Hospital
    Little Rock, Arkansas 72202-3591, United States
  • Kaiser Permanente Downey Medical Center
    Downey, California 90242, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
  • Children's Hospital and Research Center at Oakland
    Oakland, California 94609-1809, United States
  • Children's Hospital of Orange County
    Orange, California 92868, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Rady Children's Hospital - San Diego
    San Diego, California 92123, United States
  • UCSF Medical Center-Mission Bay
    San Francisco, California 94158, United States
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
  • Yale University
    New Haven, Connecticut 06520, United States
  • Alfred I duPont Hospital for Children
    Wilmington, Delaware 19803, United States
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
  • Golisano Children's Hospital of Southwest Florida
    Fort Myers, Florida 33908, United States
  • Nicklaus Children's Hospital
    Miami, Florida 33155, United States
  • AdventHealth Orlando
    Orlando, Florida 32803, United States
  • Johns Hopkins All Children's Hospital
    St. Petersburg, Florida 33701, United States
  • Children's Healthcare of Atlanta - Egleston
    Atlanta, Georgia 30322, United States
  • Kapiolani Medical Center for Women and Children
    Honolulu, Hawaii 96826, United States
  • Saint Luke's Mountain States Tumor Institute
    Boise, Idaho 83712, United States
  • Lurie Children's Hospital-Chicago
    Chicago, Illinois 60611, United States
  • University of Chicago Comprehensive Cancer Center
    Chicago, Illinois 60637, United States
  • Saint Jude Midwest Affiliate
    Peoria, Illinois 61637, United States
  • Riley Hospital for Children
    Indianapolis, Indiana 46202, United States
  • Saint Vincent Hospital and Health Care Center
    Indianapolis, Indiana 46260, United States
  • University of Kentucky/Markey Cancer Center
    Lexington, Kentucky 40536, United States
  • Ochsner Medical Center Jefferson
    New Orleans, Louisiana 70121, United States
  • Eastern Maine Medical Center
    Bangor, Maine 04401, United States
  • Maine Children's Cancer Program
    Scarborough, Maine 04074, United States
  • Johns Hopkins University/Sidney Kimmel Cancer Center
    Baltimore, Maryland 21287, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • C S Mott Children's Hospital
    Ann Arbor, Michigan 48109, United States
  • Wayne State University/Karmanos Cancer Institute
    Detroit, Michigan 48201, United States
  • Ascension Saint John Hospital
    Detroit, Michigan 48236, United States
  • Helen DeVos Children's Hospital at Spectrum Health
    Grand Rapids, Michigan 49503, United States
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
    Minneapolis, Minnesota 55404, United States
  • University of Minnesota/Masonic Cancer Center
    Minneapolis, Minnesota 55455, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Washington University School of Medicine
    St Louis, Missouri 63110, United States
  • Mercy Hospital Saint Louis
    St Louis, Missouri 63141, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Mount Sinai Hospital
    New York, New York 10029, United States
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
    New York, New York 10032, United States
  • State University of New York Upstate Medical University
    Syracuse, New York 13210, United States
  • Sanford Broadway Medical Center
    Fargo, North Dakota 58122, United States
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
  • Rainbow Babies and Childrens Hospital
    Cleveland, Ohio 44106, United States
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Children's Hospital of Pittsburgh of UPMC
    Pittsburgh, Pennsylvania 15224, United States
  • Prisma Health Richland Hospital
    Columbia, South Carolina 29203, United States
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
  • Vanderbilt University/Ingram Cancer Center
    Nashville, Tennessee 37232, United States
  • Dell Children's Medical Center of Central Texas
    Austin, Texas 78723, United States
  • UT Southwestern/Simmons Cancer Center-Dallas
    Dallas, Texas 75390, United States
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
    Houston, Texas 77030, United States
  • Primary Children's Hospital
    Salt Lake City, Utah 84113, United States
  • University of Vermont and State Agricultural College
    Burlington, Vermont 05405, United States
  • Children's Hospital of The King's Daughters
    Norfolk, Virginia 23507, United States
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
  • Providence Sacred Heart Medical Center and Children's Hospital
    Spokane, Washington 99204, United States
  • West Virginia University Healthcare
    Morgantown, West Virginia 26506, United States
  • University of Wisconsin Hospital and Clinics
    Madison, Wisconsin 53792, United States
  • Children's Hospital of Wisconsin
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 9, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02452554
Responsible party
Sponsor
First posted
May 22, 2015
Start date
Oct 12, 2015
Primary completion
Jun 30, 2017
Completion
Sep 30, 2021
Results posted
Aug 29, 2019
Last update
Jan 13, 2022

Study contacts

James I Geller
principal investigator · Children's Oncology Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Lorvotuzumab mertansine

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