ACNS1123: Phase 2 trials of response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS-GCT)

Protocol: 
AAAO2801
Phase: 
II

ACNS1123: Phase 2 trials of response-Based Radiation Therapy for Patients with Localized Central Nervous System Germ Cell Tumors (CNS-GCT)

This is a research study for subjects who have diagnosed with a type of brain tumor called a germ cell tumor. A germ cell tumor can be malignant and can sometimes spread through the brain and spinal canal before symptoms appear. Normal germ cells are the body’s reproductive cells which are usually found in reproductive organs. Germ cells typically give rise to egg cells in ovaries of females and sperm cells in the testicles of males. The current standard treatment for newly diagnosed localized germinoma germ cell tumors in the brain is radiation therapy. Until recently, the radiation was usually given to the brain and spinal cord. This type of radiation therapy is called craniospinal irradiation (or CSI). In addition, radiation has also been given as whole ventricular irradiation (or WVI). Due to the possible long term effects from radiation, this study is looking at giving WVI and reducing the radiation therapy delivered after chemotherapy in order to minimize long term effects. The current standard treatment for newly diagnosed non-germinomatous germ cell tumors (NGGCT) in the brain is chemotherapy followed by radiation therapy. This study will look at giving WVI in reduced doses for NGGCT after chemotherapy in order to decrease long term effects from radiation therapy. A total of 168 subjects will be enrolled nationwide.

Are you Eligible? (Inclusion Criteria)

-Subjects must be at least 3 years and up to 21 years of age at the time of
study entry.
-Patients must be newly diagnosed with localized primary CNS non
germinomatous germ cell tumor (NGGCT) or localized primary CNS germinoma;
germ cell tumors (GCTs) located in the suprasellar, pineal, bifocal (pineal
+suprasellar), and ventricles are eligible; tumors present in the above
mentioned locations and with unifocal parenchymal extension are eligible.
-Patients with tumors located outside the ventricles (basal ganglia,
thalamus) are not eligible.
-Patients with metastatic disease are not eligible.
-Patients must not have received any prior tumor-directed therapy other than
surgery and steroids.
-Patients must also meet all eligibility criteria as outlined in the study
protocol.