ACNS2021
This phase II trial studies the best way to combine chemotherapy and radiation therapy based on how a patient responds to induction chemotherapy. It focuses on patients with localized non-germinomatous germ cell tumors (NGGCT) that haven't spread to other parts of the brain or body (loca...
About This Study
Summary
This study has 2 goals:
- Optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses
- 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.
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
To be included in ACNS 2021, participants must be / have
- Newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region
- Aged ≥ 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
- A cranial MRI without gadolinium
To be included in ACNS 2021, participants must not be / have
- Tumors located outside the ventricles
- Only mature teratoma and non-elevated markers upon tumor sampling at diagnosis
- Received any prior tumor-directed therapy for their diagnosis of NGGCT other than surgical intervention and corticosteroids
- Metastatic disease
- Pregnant or lactating female patients
Keywords
Chemotherapy; NGGCT
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Glenn Edwards, MD, is the section chief of pediatric hematology/oncology, as well as the Children's Oncology Group's principal investigator for Carilion Clinic. With more than 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.
Official title of study
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
Funding mechanism
Sponsored by Children's Oncology Group