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Protocol No. APEC1621E

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Phase 2 Subprotocol of Selumetinib (AZD6244 Hydrogen Sulfate) in Patients with Tumors Harboring Activating MapK Pathway Mutations

Objective This is a Phase 2 study of a drug called selumetinib (AZD6244 hydrogen sulfate). In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on your tumor or type of cancer. We are using selumetinib (AZD6244 hydrogen sulfate) in this study because it has been shown to block the growth of cancer cells that have mutations in an important signaling pathway (called the MAPK pathway) in test tubes and in animals. Genes in this pathway are frequently mutated in many types of cancers. You are eligible for this study because your tumor was found to have a mutation in this pathway. Selumetinib (AZD6244 hydrogen sulfate) is considered a study drug in the treatment of your tumor or type of cancer. We do not know if it will work against the type of tumor you have

Treatment Selumetinib (AZD6244 hydrogen sulfate) will be given by mouth twice daily

Key Eligibility
  • Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to MATCH to APEC1621E based on the presence of an actionable mutation
  • Patients must be ≥ than 12 months and ≤ 21 years of age at the time of study enrollment
  • Patients must have a body surface area ≥ 0.5 m2 at enrollment
  • Patients must have radiographically measurable disease
  • Patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
  • Patients must have a Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
  • Must have adequate Bone Marrow, Renal, Liver and Cardiac function
  • Must have adequate Blood Pressure Control
  • Can not be Pregnancy or Breast-Feeding
  • Patients who have an uncontrolled infection are not eligible
  • Patients with known significant ophthalmologic conditions (uncontrolled glaucoma, history of retinal vein occlusion or retinal detachment, excluding patients with longstanding findings secondary to existing conditions) are not eligible
  • Patients with Low Grade Glioma are not eligible
  • Patients who have received a prior solid organ transplantation are not eligible

    • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions Gundersen Health System; UW Hospital and Clinics