Clinical Trial: Cancer, Brain Tumor

ACNS0831: Post-Radiation Chemotherapy (PRO00000507)

Full Name

ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 Years: A Groupwide Phase III Study

Description

All participants will receive a short course of chemotherapy, called Induction chemotherapy, which will start 2 weeks after enrolling in the study. The chemotherapy will be given over 7 weeks. After the completion of Induction therapy, participants will have scans done. What happens next will depend on the features of the participant's tumor and how it reacted to the Induction chemotherapy. If the tumor has spread into other areas (metastasized), the participant will be taken off the study, and the doctor will discuss other treatment options with them. If the tumor has completely gone away after Induction chemotherapy, the tumor was located in the upper part of their brain and the tumor cells are favorable, the participant will have no further treatment and will be carefully watched. If the tumor has completely gone away after Induction chemotherapy, but the tumor was not located in the upper part of their brain and/or the tumor cells are unfavorable, the participant will have more treatment - Participants will be randomly assigned to receive radiation therapy and more chemotherapy (maintenance), or radiation therapy and then be carefully watched. If the tumor stayed the same size or got smaller, the participant will go on to have a second surgery.

Eligibility

Inclusion Criteria

o Must be greater than 12months of age and less than 21 years of age
o Must be newly diagnosed with intracranial ependymoma, and histologically confirmed (confirmed by the study of the tumor cells)
o Must not be diagnosed with cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma or mixed glioma
o Must have adequate renal function
o Must not have had prior treatment other than surgical intervention and corticosteroids