ACNS2021: 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
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Localized Non-germinomatous Central Nervous System Germ Cell Tumor
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Age: Between 3 Year(s) - 30 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Patients must be newly diagnosed with localized primary CNS NGGCT of the suprasellar and/or pineal region by pathology and/or serum or CSF elevation of AFP above institutional normal or > 10 ng/mL or hCGß > 100 mIU/mL.
- Patients with any of the following pathological elements are eligible: endodermal sinus (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma and mixed GCT.
- Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
You may not be eligible for this study if the following are true:
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- Patients with tumors located outside the ventricles (i.e., basal ganglia, thalamus); 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 (i.e., MRI evaluation, lumbar CSF cytology or intraoperative evidence of dissemination).
- Patients in status epilepticus, coma or assisted ventilation prior to study enrollment.
- Pregnancy and Breastfeeding
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.