Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
- Refractory Non Hodgkin Lymphoma
- Refractory Malignant Glioma
- Refractory Neuroblastoma
- Recurrent Ependymoma
- Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Refractory Hepatoblastoma
- Recurrent Hepatoblastoma
- Refractory Malignant Germ Cell Tumor
- Recurrent WHO Grade II Glioma
- Recurrent Langerhans Cell Histiocytosis
- Recurrent Malignant Germ Cell Tumor
- Recurrent Malignant Glioma
- Recurrent Rhabdomyosarcoma
- Refractory Ependymoma
- Refractory Soft Tissue Sarcoma
- Refractory Medulloblastoma
- Recurrent Osteosarcoma
- Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
- Wilm's Tumor
- Recurrent Medulloblastoma
- Refractory Langerhans Cell Histiocytosis
- Refractory Osteosarcoma
- Recurrent Neuroblastoma
- Refractory Rhabdomyosarcoma
- Recurrent Non-Hodgkin Lymphoma
- Recurrent Soft Tissue Sarcoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1221 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 ...
PRIMARY OBJECTIVE: I. To determine the objective response rate (ORR; complete response + partial response) in pediatric patients treated with ensartinib with advanced solid tumors (including central nervous system [CNS] tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations. SECONDARY OBJECTIVES: I. To estimate the progression free survival in pediatric patients treated with ensartinib with advanced solid tumors (including CNS tumors), non-Hodgkin lymphomas or histiocytic disorders that harbor ALK or ROS1 fusions or that harbor ALK missense mutations. II. To obtain information about the tolerability of ensartinib in children with relapsed or refractory cancer. III. To provide preliminary estimates of the pharmacokinetics of ensartinib in children with relapsed or refractory cancer. EXPLORATORY OBJECTIVES: I. To evaluate other biomarkers as predictors of response to ensartinib and specifically, whether tumors that harbor different missense mutations or fusions (including the crizotinib resistant F1174L ALK variant) will demonstrate differential response to ensartinib treatment. II. To explore approaches to profiling changes in tumor genomics over time through evaluation of circulating tumor deoxyribonucleic acid (DNA). OUTLINE: Patients receive ensartinib orally (PO) once daily (QD) on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
Tracking Information
- NCT #
- NCT03213652
- Collaborators
- Children's Oncology Group
- Investigators
- Principal Investigator: Meredith S Irwin Children's Oncology Group