At a glance
ClinicalIndex Comparison Record- ✓Age 3 to <30 years at enrollment
- ✓Newly diagnosed localized primary CNS NGGCT of suprasellar and/or pineal region
- ✓Confirmed by pathology and/or serum/CSF elevation of AFP >10 ng/mL or hCG beta >100 mIU/mL
- ✓Eligible pathological elements: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, mixed germ cell tumor
- ✕Tumors located outside the ventricles (basal ganglia, thalamus)
- ✕Only mature teratoma with non-elevated markers at diagnosis
- ✕Pure germinoma or pure germinoma admixed with mature teratoma
- ✕Prior tumor-directed therapy other than surgical intervention and corticosteroids
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Biospecimen Collection, Carboplatin, and 11 other interventions for Central Nervous System Nongerminomatous Germ Cell Tumor and 9 related conditions. Currently recruiting, targeting 160 participants across 166 sites in 4 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Undergo collection of CSF and blood samples
Given IV
Given IV
Given subcutaneously (SC) or IV
Given IV
Undergo MRI
Given IV or orally
Given SC
Undergo PBSC transplant
Ancillary studies
Undergo WVSCI radiation therapy
Undergo radiation therapy
Undergo second-look surgery if needed
Given IV