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Protocol No. APEC1621C

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 Tazemetostat in Patients with tumors Harboring Alterations in EZH2 or Members of the SWI/SNF Complex

This is a Phase 2 study of a drug called tazemetostat. In a Phase 2 study, the goal is to find out what effects, good and/or bad, a drug has on tumors.
Tazemetostat works by blocking cell signaling proteins that are thought to be important for tumors to grow. We are using tazemetostat in this study because it has been shown to block the growth of cancer cells with mutations in an important cell-signaling pathway (called the EZH2 and SWI/SNF pathway) in test tubes and in animals. Genes in this pathway are frequently mutated in many types of cancers. To be eligible for this study tumors need to have a mutation in one of these genes. Tazemetostat is considered a study drug, we do not know if it will work against the type tumors.
Phase 1 studies of tazemetostat have been completed in adults and children with cancer. The goal of Phase 1 studies is to find the highest dose of a study drug that can be given without too many side effects. In the Phase 1 study, researchers determined the dose of tazemetostat that can be given without too many side effects. That same dose will be used for patients enrolled on this study.

Treatment Tazemetostat will be given by mouth twice a day for 28 days, for up to 2 years unless development of serious side effects or tumor worsens

Description Phase 2, Pediatric MATCH sub study with Tazemetostat for alternations in EZH2

Key Eligibility
  • Patients must be ≥ than 12 months and ≤ 21 years of age
  • Patients must have radiographically measurable disease
  • Patients with neuroblastoma who do not have measurable disease but have MIBG+ evaluable disease are eligible
  • Karnofsky ≥ 50% for patients > 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age
  • Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy
  • ≥ 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)
  • ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to Grade ≤ 1
  • If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid
  • ≥ 14 days after the last dose of a longacting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor
  • ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
  • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including DLI or boost infusion: ≥ 84 days after infusion and no evidence of GVHD
  • Autologous stem cell infusion including boost infusion: ≥ 42 days
  • ≥ 42 days after the completion of any type of cellular therapy (e.g. modified T cells, NK cells, dendritic cells, etc.)
  • ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation
  • ≥ 42 days after systemically administered radiopharmaceutical therapy
  • Patients must not have had prior exposure to tazemetostat or other inhibitor(s) of EZH2.
  • Adequate bone marrow, liver, renal, cardiac and neurological function
  • Adequate coagulation
  • Can not be pregnant or breastfeeding
  • Male and Female must use adequate birth control
  • 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