A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
A Phase II Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
About
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized).
This study has two goals:
- Optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses
- Utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy
COG# ACNS2021
Eligibility Criteria
Inclusion Criteria
- Diagnosis: Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region.
- Age: Patients must be ≥ 3 years and < 30 years at the time of study enrollment.
- Patients must have adequate renal, liver, cardiac and bone marrow function as defined by the protocol.
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
- Protocol therapy must begin within 31 calendar days of surgery or clinical diagnosis.
Exclusion Criteria
- Patients with tumors located outside the ventricles
- Patients with only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
- Patients who have received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
- Patients with metastatic disease
- Female patients who are pregnant or lactating
See Protocol Section 3 for a complete comprehensive list of Inclusion and Exclusion Criteria.
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology and the Children's Oncology Group's principal investigator for Carilion Clinic. He has over 30 years of clinical experience and is board certified by the American Board of Pediatrics in Pediatrics and Pediatric Hematology/Oncology. He completed his fellowship at Walter Reed Army Medical Center and completed his internship and residency at Tripler Army Medical Center.
Contact Information
Wendy McCarty, C.C.R.P.
Clinical Research Coordinator II
