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Results summary of St. Jude clinical trial: 

SJMB12

 
 

A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma (SJMB12)

https://www.clinicaltrials.gov/ct2/show/NCT01878617  

Why is this study being done?

Medulloblastoma is the most common cancerous brain tumor in children. In the past, its treatment was based on the amount of tumor left over after surgery and whether the tumor had spread to areas outside the brain. This is known as clinical risk. However, recent studies show that there are different types of medulloblastoma based on the tumor’s molecular make-up. The types are WNT, SHH, or Non-WNT/Non-SHH. Each type responds differently to treatment. This suggests that clinical risk alone is not enough to reduce the chances of the cancer returning after treatment.

The SJMB12 clinical trial focuses on both clinical risk and the tumor’s molecular make-up.

The study’s main goals are to:

  • Lower radiation and chemotherapy (chemo) doses to patients who have tumors that do not seem to need such high doses for cures
  • Find out if there are fewer side effects while still achieving the same survival rate as the past St. Jude study
  • Learn if adding new chemo drugs to standard chemo will improve survival

When was this study done?

The study opened in June 2013 and will close in June 2023.

What does the study consist of?

All patients have surgery to remove as much of the primary tumor as safely possible. They also receive radiation therapy and chemo. The amount of radiation therapy and the chemo used depends on the patient’s clinical risk and type of medulloblastoma. After treatment ends, the child will undergo a series of tests to find out how well treatment worked.

What have we learned thus far from this study?

Posterior fossa syndrome (PFS) develops in 25-40% of children with medulloblastoma after surgery. Children with PFS have limited or loss of speech, as well as changes in movement, emotions and behavior. We studied patients in SJMB12 to learn more about PFS. We were able to classify patients with PFS into two groups, with one type less severe than the other.

The results showed a lower incidence of PFS and less severe PFS in medical centers that treat a large number of patients with medulloblastoma. This means it is important to seek out highly experienced, specialized care from surgeons who often treat this specific type of brain tumor in children.

What are the next research steps as a result of this study?

Because the SJMB12 clinical trial is ongoing, we expect other findings to emerge in the coming months and years.

How does this study affect my child?

Every childhood cancer survivor should receive long-term follow-up care. Through the St. Jude After Completion of Care clinic, your child will receive information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines that apply to your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publication generated from this study:

Clinical features, neurologic recovery, and risk factors of post-operative posterior fossa syndrome and delayed recovery: A prospective study. Khan RB, Patay Z, Klimo P, Huang J, Kumar R, Boop FA, Raches D, Conklin HM, Sharma R, Simmons A, Sadighi ZS, Onar-Thomas A, Gajjar A, Robinson GW. Neuro Oncol. 2021 Apr 5:noab030.
https://pubmed.ncbi.nlm.nih.gov/33823018/