Purpose

This phase II Pediatric MATCH trial studies how well ensartinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that have come back (recurrent) or do not respond to treatment (refractory) and have spread to other places in the body (advanced). Ensartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Category

IRB Number
20170688HU
NCT Number
NCT03213652
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Jaclyn Hung
+1 (210) 450-5358
hungj@uthscsa.edu



Eligibility

Eligible Ages
Between 12 Months and 21 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Hematopoietic and Lymphoid Cell Neoplasm
    2. Malignant Solid Neoplasm
    3. Recurrent Ependymoma
    4. Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    5. Recurrent Hepatoblastoma
    6. Recurrent Langerhans Cell Histiocytosis
    7. Recurrent Malignant Germ Cell Tumor
    8. Recurrent Malignant Glioma
    9. Recurrent Medulloblastoma
    10. Recurrent Neuroblastoma
    11. Recurrent Non-Hodgkin Lymphoma
    12. Recurrent Osteosarcoma
    13. Recurrent Rhabdomyosarcoma
    14. Recurrent Soft Tissue Sarcoma
    15. Recurrent WHO Grade II Glioma
    16. Refractory Ependymoma
    17. Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    18. Refractory Hepatoblastoma
    19. Refractory Langerhans Cell Histiocytosis
    20. Refractory Malignant Germ Cell Tumor
    21. Refractory Malignant Glioma
    22. Refractory Medulloblastoma
    23. Refractory Neuroblastoma
    24. Refractory Non-Hodgkin Lymphoma
    25. Refractory Osteosarcoma
    26. Refractory Rhabdomyosarcoma
    27. Refractory Soft Tissue Sarcoma
    28. Wilms Tumor

      29. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (ensartinib)

      		Patients receive ensartinib PO QD on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.
    29. Drug: Ensartinib

      Given PO

      Other names:

      • X-396

    30. Other: Pharmacological Study

      Correlative studies

    31. Other: Laboratory Biomarker Analysis

      Correlative studies

      32.