Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rha… (NCT02452554) | Clinical Trial Compass
CompletedPhase 2
Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma
United States62 participantsStarted 2015-10-12
Plain-language 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.
Who can participate
Age range12 Months – 30 Years
SexALL
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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 measurem…
What they're measuring
1
Objective Response by Response Evaluation Criteria in Solid Tumors Version 1.1
Timeframe: 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