Purpose

This phase II Pediatric MATCH trial studies how well larotrectinib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Larotrectinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Category

IRB Number
20170684HU
NCT Number
NCT03213704
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. Advanced Malignant Solid Neoplasm
    2. Recurrent Ependymoma
    3. Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    4. Recurrent Glioma
    5. Recurrent Hepatoblastoma
    6. Recurrent Langerhans Cell Histiocytosis
    7. Recurrent Malignant Germ Cell Tumor
    8. Recurrent Malignant Glioma
    9. Recurrent Malignant Solid Neoplasm
    10. Recurrent Medulloblastoma
    11. Recurrent Neuroblastoma
    12. Recurrent Non-Hodgkin Lymphoma
    13. Recurrent Osteosarcoma
    14. Recurrent Rhabdoid Tumor
    15. Recurrent Rhabdomyosarcoma
    16. Recurrent Soft Tissue Sarcoma
    17. Refractory Ependymoma
    18. Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    19. Refractory Glioma
    20. Refractory Hepatoblastoma
    21. Refractory Langerhans Cell Histiocytosis
    22. Refractory Malignant Germ Cell Tumor
    23. Refractory Malignant Glioma
    24. Refractory Malignant Solid Neoplasm
    25. Refractory Neuroblastoma
    26. Refractory Non-Hodgkin Lymphoma
    27. Refractory Osteosarcoma
    28. Refractory Primary Central Nervous System Neoplasm
    29. Refractory Rhabdoid Tumor
    30. Refractory Rhabdomyosarcoma
    31. Wilms Tumor

      32. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (larotrectinib sulfate)

      		Patients receive larotrectinib sulfate PO or via NG- or G-tube twice per day (BID) on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    32. Drug: Larotrectinib Sulfate

      Given PO or via nasogastric- or gastric-tube

      Other names:

      • ARRY 470 Sulfate
      • LOXO 101 Sulfate
      • LOXO-101 Sulfate
      • Vitrakvi

    33. Drug: Larotrectinib

      Given PO or via nasogastric- or gastric-tube

      Other names:

      • ARRY 470
      • LOXO 101
      • LOXO-101

      34.