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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

Objective

1.1.1 To monitor outcome 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 response evaluation and whole ventricular + spinal canal irradiation (WVSCI) will maintain the excellent 2-year progression free survival (PFS) rate as compared to ACNS0122. 1.1.2 To improve disease control by decreasing the number of spinal relapses for patients who achieve a complete response (CR) or partial response (PR) and receive WVSCI as compared to whole ventricular radiation on ACNS1123.

Protocol #

ACNS2021

Trial Phase:

Phase II

Principal Investigator:

Park, Christopher

Cancer Type
  • Brain and Nervous System
Study Site
  • Virginia Commonwealth University

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 CSF elevation of AFP above institutional normal or > 10 ng/mL or hCGB > 100 mIU/mL. Suprasellar, pineal and bifocal tumors are included. 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 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).

Get more detailed information at ClinicalTrials.gov

  • Enrollment Status 1
  • Age Group Both
  • Protocol Type Treatment
  • Research Study Team Lindsey Gwaltney, MS, RN
    Phone: +1 804-628-2112
    Email Study Contact

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