What is the Purpose of this Study?
This study focuses on individuals who have been diagnosed with a type of brain cancer called non-germinomatous germ cell tumor (NGGCT) and whose tumor is “localized” (has not spread to other parts of the brain or body). The purpose of the study is to determine whether radiation therapy (RT) to the spine and a portion of the brain works as well as the standard treatment (which includes RT to the whole brain and spine) in people with NGGCT. Researchers want to learn whether they can lower the number of relapses in the spine in patients who receive RT to the spine and a portion of the brain only, as compared to patients in previous studies who received radiation to a portion of the brain only and none to the spine. The study also aims to determine whether treatment with a high dose of chemotherapy and stem cell rescue improves the treatment response and outcome in patients who do not have a good response to the first phase of chemotherapy (induction). The treatment in this study involves chemotherapy and high-energy X-rays (radiation therapy).
Eligibility
- * Patients must be \>= 3 years and \< 30 years at the time of study enrollment
- * Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or cerebrospinal fluid (CSF) elevation of AFP above institutional normal or \> 10 ng/mL or human chorionic gonadotropin (hCG) beta \> 100 mIU/mL as confirmed by Rapid Central Marker Screening Review on APEC14B1-CNS. Suprasellar, pineal and bifocal tumors are included. (CSF tumor markers and cytology must be within 31 days prior to enrollment and start of protocol therapy \[repeat if necessary\]. Serum tumor markers, AFP and hCGbeta must be within 7 days prior to enrollment and start of protocol therapy \[repeat if necessary\]). Basal ganglia or other primary sites are excluded
- * Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed germ cell tumor (GCT) (i.e., may include some pure germinoma) if malignant elements listed above are present. Patients with only mature teratoma are excluded. Patients with pure germinoma admixed with mature teratoma are excluded (would be eligible for pure germinoma protocols)
- * Patients must have a cranial MRI with and without gadolinium at diagnosis/prior to enrollment. If surgical resection is performed, patients must have pre-operative and post operative brain MRI with and without gadolinium. The post operative brain MRI should be obtained within 72 hours of surgery. If patient has a biopsy only, post-operative brain MRI is recommended but not required (within 31 days prior to study enrollment and start of protocol therapy )
Where can I participate?
CS Cancer at Cedars-Sinai Medical Center : Amy Oppenheim
More about this Clinical Trial
What is the full name of this clinical trial?
A Phase 2 Trial of Chemotherapy followed by Response-Based Whole Ventricular & Spinal Canal Irradiation for Patients with Localized Non-Germinomatous Central Nervous System Germ Cell Tumor ^