Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Conditions

• Advanced Malignant Solid Neoplasm
• Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma
• Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma
• Recurrent Childhood Central Nervous System Neoplasm
• Recurrent Childhood Non-Hodgkin Lymphoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Neuroblastoma
• Refractory Malignant Solid Neoplasm
• Refractory Neuroblastoma
• Refractory Non-Hodgkin Lymphoma
• Refractory Primary Central Nervous System Neoplasm

Eligibility Criteria

Sex

ALL

Age

12 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Selumetinib — DRUG
  Given PO
• Selumetinib Sulfate — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Oct 30, 2017

Status verified

Jan 2025

Primary completion

Jun 30, 2021

Completion

Dec 31, 2024

Study Design

Enrollment

21 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Response Rate [ Time Frame: From enrollment to the end of treatment, up to 2 years ]

Locations (108)

Find similar trials in Birmingham, AL

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