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.]

NCT01878617 : A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma
PhasePhase 2
AgesMin: 3 Years Max: 39 Years
Eligibility
INCLUSION CRITERIA

- Medulloblastoma or medulloblastoma variants including posterior fossa PNET as
documented by an institutional pathologist.

- Participant's age meets one of the following: (1) Age greater than or equal to 3 years
and less than 22 years of age at the time of diagnosis (may enroll on Strata W, S or
N), OR (2) age is greater than or equal to 22 years and less than 40 years AND patient
has SHH medulloblastoma (must enroll on Stratum S).

- No previous radiotherapy, chemotherapy or other brain tumor directed therapy other
than corticosteroid therapy and surgery.

- Patients must begin treatment as outlined in the protocol within 36 days of definitive
surgery (day of surgery is day 0; definitive surgery includes second surgeries to
resect residual tumor).

- Adequate performance status: children < 10-Lansky Score = 30; children = 10-Karnofsky
= 30 (except for posterior fossa syndrome).

- Females of child-bearing potential cannot be pregnant or breast-feeding. Female
participants > 10 years of age or post-menarche must have a negative serum or urine
pregnancy test prior to enrollment.

- Biological parent(s) of participant (child) enrolling on this protocol. These parents
will be assigned to cohort P. The exclusion criteria below do not apply to this
cohort.

EXCLUSION CRITERIA

- CNS embryonal tumor other than medulloblastoma or PNET in the posterior fossa, for
example, patients with diagnosis of Atypical Teratoid / Rhabdoid Tumor (ATRT),
supratentorial PNET, pineoblastoma, ependymoblastoma, ETANTR are excluded.

- Research participants with other clinically significant medical disorders that could
compromise their ability to tolerate protocol therapy or would interfere with the
study procedures or results history.

Participants in the Stratum S maintenance chemotherapy portion of the study must meet the
criteria below prior to start of vismodegib therapy:

- Participants must be Stratum S (SHH)

- Participants must be skeletally mature defined as females with a bone age = 15 years
and males with a bone age = 17 years.

- Must be able to swallow pills

- BSA must be >0.67 and <2.5 m2

- Male and female participants of reproductive potential must agree to effective
contraception during and after study treatment. See Appendices I and II for further
guidance for participants receiving vismodegib

- ANC > 1000/mm^3 (after G-CSF discontinued)

- Platelets > 50,000/mm^3 (without support)

- Hgb > 8 g/dL (with or without transfusion support)

- Serum creatinine = 1.5 mg/dL

- Total bilirubin = 1.5X the institutional ULN

- SGPT (ALT) = 2.5X the institutional ULN

- SGOT (AST) = 2.5X the institutional ULN

- Alkaline Phosphatase = 1.5X the institutional ULN

Participants in the exercise intervention portion of the study must meet all criteria
below:

- Must be = 5 years and < 22 years at the time of enrollment

- Must have no congenital heart disease

- Must be capable of performing the exercise intervention at the time of baseline
assessment as determined by the treating physician.

Participants in the cognitive remediation intervention portion of the study must meet all
criteria below:

- Completed protocol-directed radiation therapy

- =5 years at the time of remediation intervention consent

- English as primary language and training aide who speaks English available to
participate in required sessions

- No significant cognitive impairment operationalized as either an IQ < 70 for children
with St. Jude SJMB12 study baseline testing or based on clinician judgment baseline IQ
missing

- No major sensory or motor impairment that would preclude valid cognitive testing
(e.g., unresolved posterior fossa syndrome, blindness, poorly controlled
seizures/photosensitive epilepsy, psychosis) or a major psychological condition that
would preclude completion of the intervention (e.g., significant oppositionality,
autism spectrum disorder, severe anxiety or depressive symptoms)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01878617      |      Link to official Clinicaltrials.gov listing
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