Purpose

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

Category

IRB Number
20170687HU
NCT Number
NCT03213691
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. Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
    3. Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
    4. Recurrent Childhood Central Nervous System Neoplasm
    5. Recurrent Childhood Non-Hodgkin Lymphoma
    6. Recurrent Malignant Solid Neoplasm
    7. Recurrent Neuroblastoma
    8. Refractory Malignant Solid Neoplasm
    9. Refractory Neuroblastoma
    10. Refractory Non-Hodgkin Lymphoma
    11. Refractory Primary Central Nervous System Neoplasm

      12. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (selumetinib)

      		Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    12. Drug: Selumetinib

      Given PO

      Other names:

      • ARRY-142886
      • AZD6244
      • MEK Inhibitor AZD6244

    13. Other: Laboratory Biomarker Analysis

      Correlative studies

    14. Drug: Selumetinib Sulfate

      Given PO

      Other names:

      • AZD-6244 Hydrogen Sulfate
      • AZD6244 Hydrogen Sulfate
      • AZD6244 Hydrogen Sulphate
      • Koselugo
      • Selumetinib Sulphate

      15.