A Study of a New Way to Treat Children and Young Adults With a Brain Tumor Called NGGCT
About
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
This phase II trial studies the best approach to combine chemotherapy and radiation therapy based on the patient’s 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: (1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, (2) utilizing higher doses of chemotherapy followed by conventional radiation therapy in patients who did not respond to induction chemotherapy. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next.
Study Plan: This study wants to monitor outcomes to ensure that children and young adults with localized central nervous system (CNS) non-germinomatous germ cell tumors (NGGCT) treated with induction chemotherapy followed by a response evaluation and whole ventricular plus spinal canal irradiation will maintain the excellent 2-year progression free survival rate. It also wants to improve disease control by decreasing the number of spinal relapses in patients who achieve a complete response (CR) or partial response (PR).
Arm 1: Chemotherapy, WVSCI radiation therapy, second look at surgery if needed
Arm 2: Chemotherapy, HDCSCR consolidation therapy, second look at surgery if needed, peripheral blood stem cell transplant, radiation therapy
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
- 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
- Patients must have a cranial MRI without gadolinium
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
- Pregnant or lactating female patients
Primary Investigator
Dr. Glenn Edwards is the section chief of Pediatric Hematology/Oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. With over 30 years of clinical experience, he 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, CCRP
Clinical Research Coordinator
Sydnee Moses, BS
Clinical Research Coordinator
