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 &Amp; Spinal Canal Irradiation (WVSCI) for Patients With Localized Non-Germinomatous Central Nervous System Germ Cell Tumor
About This Trial
This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) 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 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. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Biospecimen Collection
Undergo collection of CSF and blood samples
Carboplatin
Given IV
Etoposide
Given IV
Filgrastim
Given subcutaneously (SC) or IV
Ifosfamide
Given IV
Magnetic Resonance Imaging
Undergo MRI
Mesna
Given IV or orally
Pegfilgrastim
Given SC
Peripheral Blood Stem Cell Transplantation
Undergo PBSC transplant
Questionnaire Administration
Ancillary studies
Radiation Therapy
Undergo WVSCI radiation therapy
Radiation Therapy
Undergo radiation therapy
Second-Look Surgery
Undergo second-look surgery if needed
Thiotepa
Given IV