ACNS1021, A Phase II Study of Sunitinib (NSC# 736511, IND# 74019) in Recurrent, Refractory or Progressive High Grade Glioma and Ependymoma Tumors in Pediatric and Young Adult Patients
Eligible participants will take Sunitinib by mouth once daily for 28 days. There will then
be a 14-day rest period. The 28 days of therapy and the 14-day rest period (total of 42
days) is known as a Cycle of treatment. All subjects on this study will begin treatment
with the same dose of sunitinib. If a participant completes 2 cycles of therapy without
having severe side effects then the study doctor may increase the dose of sunitinib.
Participants may continue to receive sunitinib for up to 18 cycles unless they develop
serious side effects or the tumor worsens. Participants will not need to be hospitalized
when the sunitinib is being given. But hospitalization may become necessary if severe
side effects to sunitinib or a tumor related illness occur.
Participants will receive screening studies to monitor for possible problems affecting
heart function and bone development. These screening studies include a test called an
EKG to monitor heart function throughout the study treatment and x-rays of the knee to
monitor for any bone development problems. These studies may not be performed as
part of other chemotherapy treatments but are being done on this trial as a precaution.
Participants will receive standard scans, called an MRI, to provide images of the tumor
throughout treatment and after treatment has ended so that study doctors can see how
the tumor is responding to therapy. On this study, if the tumor responds to therapy then
1 more MRI scan than is usual will be performed so that study doctors can confirm the
-- Patients must be greater than or equal to 18 months and less than 22 years of age at the time of study enrollment.
--Patients must be diagnosed with ependymoma or high grade glioma (WHO Grade III/IV):
Stratum A: recurrent/progressive/refractory malignant glioma (ie, anaplastic astrocytoma,
glioblastoma multiforme [including giant cell and gliosarcoma types], anaplastic
oligodendroglioma, anaplastic oligoastrocytoma or anaplastic ganglioglioma) within the brain
with or without spinal cord disease.
Stratum B: recurrent/progressive/refractory ependymoma (including ependymoma variants)
within the brain with or without spinal cord disease.
--A histological diagnosis from either the initial presentation or at the time of recurrence is required.
--Patients must have radiographically documented measurable disease in the brain, defined as at least one lesion that can be accurately measured in at least 2 planes.
-- All patients must have a brain MRI with and without gadolinium and a spine MRI if clinically indicated with and without gadolinium performed within 2 weeks prior to study enrollment.
-- Patients must have a performance status corresponding to ECOG scores of 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients < = 16 years of age.
-- Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
-- Adequate bone marrow, renal, liver, coagulation, CNS and cardiac function.
-- Patient must have ability to take oral medication, either by mouth or via gastric tube.