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NCT01878617

NCT01878617
Active, Not Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with medulloblastoma (a type of brain tumor) or a closely related type of brain tumor in the back of the brain, confirmed by a pathologist.
  • You are between 3 and 21 years old at the time of diagnosis, OR you are between 22 and 39 years old and have a specific type called SHH medulloblastoma.
  • You have not yet received any radiation therapy, chemotherapy, or other brain tumor treatments (steroid medications and surgery are okay).
  • You are able to start treatment within 36 days of your main surgery to remove the tumor.
  • You are well enough to participate, based on standard medical scoring systems used to measure how well a patient can carry out daily activities.
  • If you are a female who could become pregnant (generally over age 10 or after your first period), you must test negative for pregnancy before joining and must not be breastfeeding.
  • Biological parents of a child enrolling in this trial may also be able to participate in a separate part of the study (the exclusion criteria listed below do not apply to parents).

Who may not be able to join:

  • You have a different type of brain tumor — such as Atypical Teratoid/Rhabdoid Tumor (ATRT), pineoblastoma, or certain other related tumors — rather than medulloblastoma or a posterior fossa PNET.
  • You have other serious medical conditions that could make it unsafe to receive the trial treatments or that could interfere with the study results.

For a specific part of the trial involving a medication called vismodegib, you would also need to:

  • Have the SHH type of medulloblastoma.
  • Have bones that are fully or nearly fully grown (females with a bone age of at least 15 years, males at least 17 years) (confirm with trial site).
  • Be able to swallow pills.
  • Have a body surface area (a measure based on your height and weight) within a specific range (confirm with trial site).
  • Agree to use effective birth control during and after treatment if you are able to have children.
  • Have blood counts, kidney function, and liver function results within acceptable ranges as measured by blood tests (confirm with trial site).

For a part of the trial involving an exercise program, you would also need to:

  • Be between 5 and 21 years old at the time of joining this part.
  • Have no congenital (present from birth) heart disease.
  • Be physically able to take part in the exercise program, as decided by your doctor.

For a part of the trial involving a brain training/thinking skills program, you would also need to:

  • Have already completed the radiation therapy required by the study.
  • Be at least 5 years old, OR between 22 and 39 with SHH medulloblastoma.
  • Speak English as your primary language and have a helper who also speaks English available to join sessions.
  • Not have a significantly low IQ score (below 70), as measured by study testing or a doctor's assessment.
  • Not have major vision, movement, or other difficulties that would prevent valid thinking/memory testing, and no major psychological conditions that would prevent completing the program (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Active, Not Recruiting
Phase
Phase 2
Sponsor
St. Jude Children's Research Hospital
Registry
clinicaltrials_gov
Start date
23 June 2013
Est. completion
13 October 2028

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Progression-free Survival in Stratum W1; Progression-free Survival in Stratum N1; Progression-free Survival in Stratum S1 Skeletally Mature Cohort; Change in VO2 Peak Value; Change in Spatial Span Backward Standard Score

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov