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
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Clinical Trial Information
Trial Contact: Parker, Melanie; Dubberly, Paige D; Doyle, Katherine M; Armatti, Julie M; Spinelli, Jennifer
Trial Phone: 321-843-1036 ; 321-841-7561 ; 3218412008 ; 321-843-5284 ; 321.841.5357
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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
ClinicalTrials.gov ID: NCT04684368
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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.
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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
