A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT

A Phase 2 Trial of Chemotherapy Followed by Response-Based Whole Ventricular & Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor

  • Clinical Trial Information

    Trial Contact: Parker, Melanie; Dubberly, Paige D; Doyle, Katherine M; Armatti, Julie M; Spinelli, Jennifer

  • IRB No: ACNS2021

    Protocol Abbrev: ACNS2021

    Principal Investigator: Amy A. Smith, MD

    Phase: Drug: Phase II

    Age Group: Pediatric

    Secondary Protocol No: ACNS2021

    Treatment: Drug: Carboplatin; Drug: Etoposide; Biological: Filgrastim; Drug: Ifosfamide; Drug: Mesna; Biological: Pegfilgrastim; Procedure: Peripheral Blood Stem Cell Transplantation; Other: Questionnaire Administration; Radiation: Radiation Therapy; Procedure: Second-Look Surgery; Drug: Thiotepa

    Therapies Involved: Chemotherapy; Surgery ID: NCT04684368

  • Objective

    This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy.

  • Key Eligibility

    - Patients must be >= 3 years and < 30 years at the time of study enrollment
    - Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or > 10 ng/mL or human chorionic gonadotropin (hCG) beta > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 21 days prior to enrollment and within 35 days prior to start of protocol therapy [repeat if necessary]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy [repeat if necessary]). Basal ganglia or other primary sites are excluded