Treatment of Patients With Newly Diagnosed Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
- To compare the effects of a computer-based training system specifically targeting
language, reading, and learning skills (Fast ForWord, Scientific Learning Corporation)
with the current standard of care on reading decoding skills as measured by individual
- To monitor for treatment failure in the posterior fossa of patients whose tumor bed
receives a reduced volume of radiation.
- To correlate radiation dosimetry of target and normal tissues with rate and patterns of
failure and longitudinal measures of audiometric, endocrine and cognitive effects.
- To estimate the change in neuropsychological performance from the neuropsychology
assessment battery (intellect, academic achievement and cognitive ability) and examine
the relationship of these changes to risk group, age at diagnosis, and parent measures.
- To evaluate the differences between neurotoxicity in the average-risk patient group
with that in the high-risk group through qMRI, and fMRI.
- To develop or refine novel models relating impact of medulloblastoma therapy on
neurocognitive performance to quantitative and functional neuroimaging measures.
OUTLINE: This is a multicenter study. Patients are stratified according to disease risk
(high-risk disease vs average-risk disease).
Patients in both strata undergo peripheral blood stem cell or bone marrow harvest.
- Stratum 1 (high-risk group):
- Radiotherapy: Patients undergo craniospinal radiotherapy once daily 5 days a week
for 6 weeks.
- High-dose chemotherapy and autologous stem cell transplantation (SCT): Six weeks
after the completion of radiotherapy, patients receive high-dose chemotherapy
comprising vincristine IV followed by cisplatin IV over 6 hours on day -4 and
cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous SCT
on day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1
and continuing until blood counts recover. Patients receive vincristine IV on day
6. High-dose chemotherapy and autologous SCT repeat every 4 weeks for 3 additional
courses in the absence of unacceptable toxicity.
- Stratum 2 (average-risk group):
- Radiotherapy: Patients undergo craniospinal radiotherapy as in stratum 1, but at a
- High-dose chemotherapy and autologous SCT: Patients receive high-dose
chemotherapy, autologous SCT, G-CSF, and post-transplantation vincristine as in
Some patients undergo a neuropsychology assessment at baseline, before chemotherapy, and
then annually for 5 years.
After completion of study therapy, patients are followed every 3 months until month 30 (2.5
years) after diagnosis and then every 6 months until month 72 (6 years) after diagnosis.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival in ERBB2-negative tumors compared to ERBB2-positive tumors
To assess the relationship between ERBB2 protein expression in tumors and progression-free survival for patients with medulloblastoma
2 years after tumor cell analysis in 123 patients
Amar Gajjar, MD
St. Jude Children's Research Hospital
United States: Food and Drug Administration
|Children's Hospital of Philadelphia||Philadelphia, Pennsylvania 19104|
|Duke Comprehensive Cancer Center||Durham, North Carolina 27710|
|St. Jude Children's Research Hospital||Memphis, Tennessee 38105-2794|
|Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital||Houston, Texas 77030-2399|