A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma
- Determine the feasibility of combining post-operative intrathecal radioimmunotherapy,
craniospinal radiotherapy with intensity-modulated radiotherapy boost, and chemotherapy
in patients with standard-risk medulloblastoma.
- Determine whether this regimen can maintain or exceed the current progression-free
survival rate while decreasing long-term serious morbidity in these patients.
- Determine the long-term morbidities, most specifically neuropsychological,
neuroendocrine, audiometric, and growth outcomes, in patients treated with this
- Radioimmunotherapy: Patients receive intrathecal iodine I 131 monoclonal antibody 3F8
on days 1 and 8.
- Radiotherapy: Beginning as soon as possible after radioimmunotherapy, patients undergo
external-beam and intensity-modulated radiotherapy 5 days a week for 6 weeks.
- Chemotherapy: Patients receive vincristine IV once weekly for 8 weeks concurrently with
radiotherapy. Beginning about 6 weeks after completion of radiotherapy (4 weeks after
vincristine), patients receive cisplatin IV over 6 hours and oral lomustine on day 0
and vincristine IV on days 0, 7, and 14. Treatment repeats every 6 weeks for up to 8
courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study within 3.2 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Ira Dunkel, MD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center||New York, New York 10032|