Purpose

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

Category

IRB Number
20170709HU
NCT Number
NCT03210714
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Anne-Marie Langevin

Regulatory Point of Contact
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. Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
    3. Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
    4. Low Grade Glioma
    5. Malignant Glioma
    6. Recurrent Childhood Ependymoma
    7. Recurrent Childhood Malignant Germ Cell Tumor
    8. Recurrent Childhood Medulloblastoma
    9. Recurrent Childhood Non-Hodgkin Lymphoma
    10. Recurrent Childhood Rhabdomyosarcoma
    11. Recurrent Childhood Soft Tissue Sarcoma
    12. Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
    13. Recurrent Hepatoblastoma
    14. Recurrent Langerhans Cell Histiocytosis
    15. Recurrent Malignant Solid Neoplasm
    16. Recurrent Neuroblastoma
    17. Recurrent Osteosarcoma
    18. Recurrent Primary Central Nervous System Neoplasm
    19. Refractory Langerhans Cell Histiocytosis
    20. Refractory Malignant Solid Neoplasm
    21. Refractory Neuroblastoma
    22. Refractory Non-Hodgkin Lymphoma
    23. Refractory Primary Central Nervous System Neoplasm
    24. Rhabdoid Tumor
    25. Stage III Soft Tissue Sarcoma AJCC v7
    26. Stage IV Soft Tissue Sarcoma AJCC v7
    27. Wilms Tumor
    28. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (erdafitinib)

      Patients receive erdafitinib PO QD on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    29. Other: Laboratory Biomarker Analysis

      Correlative studies

    30. Drug: Erdafitinib

      Given PO

      Other names:

      • Balversa
      • JNJ-42756493

    31. Other: Pharmacological Study

      Correlative studies