Phase 2 N=62 Treatment

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

Pleuropulmonary Blastoma · Recurrent Malignant Peripheral Nerve Sheath Tumor · Recurrent Neuroblastoma · Recurrent Rhabdomyosarcoma · Recurrent Synovial Sarcoma

Bottom Line

View on ClinicalTrials.gov: NCT02452554 ↗

Enrolled (actual)

Serious AEs

31.7%

Results posted

Aug 2019

Primary outcome: Primary: Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1 — 0.00; 6.25; 0.00; 0.00 Percent of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Laboratory Biomarker Analysis (Other); Lorvotuzumab Mertansine (Biological); Pharmacological Study (Other)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1	0.00; 6.25; 0.00; 0.00; 0.00; 0.00	—
PRIMARY Incidence of Toxicities of Lorvotuzumab Mertansine, Using the NCI Common Terminology Criteria for Adverse Events Version 4.0	0; 2; 0; 0; 0; 0	—

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.

Eligibility Criteria

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 = = 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 = 16 years: maximum serum creatinine: 1.7 mg/dL in males and 1.4 mg/dL in females
Total bilirubin = = 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

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

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Data sourced from ClinicalTrials.gov (NCT02452554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.