Purpose

This phase II Pediatric MATCH trial studies how well ulixertinib works in treating patients with solid tumors that have spread to other places in the body (advanced), non-Hodgkin lymphoma, or histiocytic disorders that have a genetic alteration (mutation) in a signaling pathway called MAPK. A signaling pathway consists of a group of molecules in a cell that control one or more cell functions. Genes in the MAPK pathway are frequently mutated in many types of cancers. Ulixertinib may stop the growth of cancer cells that have mutations in the MAPK pathway.

Category

IRB Number
20180790HU
NCT Number
NCT03698994
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

Anne-Marie Langevin
(210) 567-7460
langevin@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. Advanced Malignant Solid Neoplasm
    2. Recurrent Ependymal Tumor
    3. Recurrent Ewing Sarcoma
    4. Recurrent Glioma
    5. Recurrent Hepatoblastoma
    6. Recurrent Histiocytic and Dendritic Cell Neoplasm
    7. Recurrent Langerhans Cell Histiocytosis
    8. Recurrent Malignant Germ Cell Tumor
    9. Recurrent Malignant Solid Neoplasm
    10. Recurrent Medulloblastoma
    11. Recurrent Neuroblastoma
    12. Recurrent Non-Hodgkin Lymphoma
    13. Recurrent Osteosarcoma
    14. Recurrent Peripheral Primitive Neuroectodermal Tumor
    15. Recurrent Primary Malignant Central Nervous System Neoplasm
    16. Recurrent Rhabdoid Tumor
    17. Recurrent Rhabdomyosarcoma
    18. Recurrent Soft Tissue Sarcoma
    19. Refractory Ependymoma
    20. Refractory Ewing Sarcoma
    21. Refractory Glioma
    22. Refractory Hepatoblastoma
    23. Refractory Histiocytic and Dendritic Cell Neoplasm
    24. Refractory Langerhans Cell Histiocytosis
    25. Refractory Malignant Germ Cell Tumor
    26. Refractory Malignant Solid Neoplasm
    27. Refractory Medulloblastoma
    28. Refractory Neuroblastoma
    29. Refractory Non-Hodgkin Lymphoma
    30. Refractory Osteosarcoma
    31. Refractory Peripheral Primitive Neuroectodermal Tumor
    32. Refractory Primary Malignant Central Nervous System Neoplasm
    33. Refractory Rhabdoid Tumor
    34. Refractory Rhabdomyosarcoma
    35. Refractory Soft Tissue Sarcoma
    36. Wilms Tumor

      37. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (ulixertinib)

      		Patients receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    37. Drug: Ulixertinib

      Given PO

      Other names:

      • BVD-523
      • VRT752271

    38. Other: Pharmacokinetic Study

      Ancillary studies

      Other names:

      • PHARMACOKINETIC
      • PK Study

      39.