Clinical Trial Details
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NCT02724579 : Reduced Craniospinal Radiation Therapy and Chemotherapy in Treating Younger Patients With Newly Diagnosed WNT-Driven Medulloblastoma
PhasePhase 2
AgesMin: 3 Years Max: 21 Years
Inclusion Criteria:

- Patients must be newly diagnosed and have a confirmed molecular diagnosis of classical
histologic type (non large cell/anaplastic [LC/A]) WNT medulloblastoma from rapid
central pathology screening review on APEC14B1 (immunohistochemistry [IHC]/molecular
screening [positive nuclear beta (B)-catenin by IHC and positive for catenin beta 1
[CTNNB1] mutation) and confirmation of =< 1.5 cm^2 maximal cross-sectional area of
residual tumor from rapid central imaging review

- Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for
staging should be performed preferably no sooner than 14 days post operatively to
avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to
allow for final staging status before enrollment onto the study

- Note: patients with positive CSF cytology obtained prior to 14 days after surgery
may have cytology repeated to determine eligibility and final CSF status

- Patients must have eligibility confirmed by rapid central imaging review on APEC14B1;
standard whole brain magnetic resonance imaging (MRI) with and without contrast
(gadolinium) and spine MRI with contrast (gadolinium) must be performed at the
following time points:

- Pre-operative to include an MRI of the brain with and without contrast (including
post-contrast three-dimensional [3D] T1-weighted image [T1WI] and post-contrast
fluid-attenuated inversion recovery [FLAIR])

- Pre-operative spinal MRI with gadolinium; post-operative staging spinal MRI may
be obtained if pre-operative imaging is not possible or is suboptimal;
pre-operative spine imaging is strongly preferred, due to the potential of
post-operative sequelae, which could affect metastasis detection

- Post-operative brain MRI within 72 hours of surgery

- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1422

- Patients must be enrolled within 36 days of definitive diagnostic surgery (day 0)

- Note: patients must begin treatment within 36 days of definitive surgery

- Patients must have no previous radiotherapy or chemotherapy other than corticosteroids

- Peripheral absolute neutrophil count (ANC) >= 1000/uL

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 10.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- 3 to < 6 years of age: maximum (max) serum creatinine 0.8 mg/dL (males and

- 6 to < 10 years of age: max serum creatinine 1 mg/dL (males and females)

- 10 to < 13 years of age: max serum creatinine 1.2 mg/dL (males and females)

- 13 to < 16 years of age: max serum creatinine 1.5 md/dL (males) and 1.4 md/dL

- >= 16 years of age: max serum creatinine 1.7 mg/dL (males) and 1.4 mg/dL

- The threshold creatinine values were derived from the Schwartz formula for
estimating GFR utilizing child length and stature data published by the
Centers for Disease Control and Prevention (CDC)

- Total or direct bilirubin =< 1.5 x upper limit of normal (ULN) for age, and

- Serum glutamate pyruvate (SGPT) (alanine aminotransferase [ALT]) =< 110 U/L (for the
purpose of this study, the upper limit of normal [ULN] for SGPT is 45 U/L)

- Central nervous system function defined as:

- Patients with seizure disorder may be enrolled if on anticonvulsants and well

- Patients must not be in status epilepticus, a coma or on assisted ventilation at
the time of study enrollment

- All patients and/or their parents or legal guardians must sign a written informed
consent; assent, when appropriate, will be obtained according to institutional

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met

Exclusion Criteria:

- Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar
CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture
for assessment of CSF cytology are ineligible

- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
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