Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

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
Eligibility
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
females)

- 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
(females)

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

- 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
controlled

- 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
guidelines

- 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
infants

- 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
participation
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02724579      |      Link to official Clinicaltrials.gov listing
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