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Alisertib in Recurrent or Progressive CNS Patients

SJATRT - Phase 2 Study Of Alisertib As A Single Agent In Recurrent Or Progressive Central Nervous System (CNS) Atypical Teratoid Rhabdoid Tumors (AT/RT) And Extra-Cns Malignant Rhabdoid Tumors (MRT) And In Combination Therapy In Newly Diagnosed At/Rt

November 22, 2017

  • Clinical Trial Information

    Trial Contact: El-Shami, Jessica; Leffin, Melissa; Francois, Laetitia Claire; Spinelli, Jennifer

  • IRB No: 15.118.09

    Protocol Abbrev: SJATRT

    Principal Investigator: Amy A Smith, MD

    Sub Investigators: AguilarBonilla, Ana MD; Eslin, Don MD; Giusti, Vincent MD; Levy, Alejandro MD; Pope, Michele ARNP; Ramakrishna, Naren MD; Smith, Amy MD; Story, Allison ARNP; Sutphin, Robert MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: SJATRT

    Treatment: Medication; Chemotherapy

    Applicable Disease Sites: Rhabdoid Tumors

    Therapies Involved: Drug: alisertib; Procedure: Surgical Resection; Drug: methotrexate; Drug: cisplatin; Drug:carboplatin; Drug: cyclophosphamide; Drug: etoposide; Drug: topotecan; Drug: vincristine; Radiation: Radiation therapy; Drug: cytoxan

    ClinicalTrials.gov ID: NCT02114229

  • Objective

    To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive AT/RT (atypical teratoid rhabdoid tumor in the CNS) (Stratum A1) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population.
    •  To estimate the sustained objective response rate and disease stabilization in pediatric patients with recurrent or progressive extra-CNS MRT (malignant rhabdoid tumor outside the CNS) (Stratum A2) treated with alisertib and to determine if the response is sufficient to merit continued investigation of alisertib in this population.
    •  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are younger than 36 months of age at diagnosis with no metastatic disease (Stratum B1) treated with alisertib in sequence with induction and consolidation chemotherapy and radiation therapy (depending on age) and to determine if the rates are sufficient to merit continued investigation of alisertib in this population.
    •  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are younger than 36 months of age at diagnosis, with metastatic disease (Stratum B2) treated with alisertib in sequence with induction and consolidation chemotherapy and to determine if the rates are sufficient to merit continued investigation of alisertib in this population.
    •  To estimate the 3-year PFS rate of patients with newly diagnosed AT/RT who are 3 years of age or greater at diagnosis with no metastatic disease and gross total resection or near total resection (Stratum C1) treated with alisertib in sequence with radiation therapy and consolidation chemotherapy and to determine if the rates are sufficient to merit continued investigation of alisertib in this population.
    •  To estimate the 1-year PFS rate of patients with newly diagnosed AT/RT who are 3 years of age or greater at diagnosis with metastatic or residual disease (Stratum C2) treated with alisertib in sequence with radiation therapy and consolidation chemotherapy and to determine if the rates are sufficient to merit continued investigation of alisertib in this population.
    •  To characterize the pharmacokinetics and pharmacodynamics of alisertib in pediatric patients and to relate drug disposition to toxicity

  • Key Eligibility

    Ages Eligible for Study: up to 21 Years Genders Eligible for Study: Both
    Accepts Healthy Volunteers: No