Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Recurrent Hepatoblastoma
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm
  • Recurrent Ependymoma
  • Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Refractory Ependymoma
  • Refractory Soft Tissue Sarcoma
  • Refractory Medulloblastoma
  • Recurrent Rhabdomyosarcoma
  • Refractory Hepatoblastoma
  • Recurrent Langerhans Cell Histiocytosis
  • Recurrent Malignant Germ Cell Tumor
  • Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
  • Refractory Neuroblastoma
  • Recurrent Malignant Glioma
  • Refractory Non Hodgkin Lymphoma
  • Refractory Osteosarcoma
  • Recurrent Medulloblastoma
  • Refractory Malignant Glioma
  • Recurrent Osteosarcoma
  • Recurrent Neuroblastoma
  • Recurrent Soft Tissue Sarcoma
  • Refractory Malignant Germ Cell Tumor
  • Recurrent Non-Hodgkin Lymphoma
  • Wilm's Tumor
  • Refractory Langerhans Cell Histiocytosis
  • Refractory Rhabdomyosarcoma
  • Recurrent WHO Grade II Glioma
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