This pilot clinical trial studies how well craniospinal irradiation using proton beam scanning with vertebral body sparing works in improving bone marrow reserve and decreasing growth decrement in children with brain tumors. Proton beam scanning with vertebral body sparing may help to reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03281889.
PRIMARY OBJECTIVES:
I. To determine the feasibility of vertebral body sparing cranio-spinal irradiation using pencil beam scanning intensity-modulated proton therapy based on the occurrence of grade 4 hematologic toxicity attributable to radiation or a hemoglobin (HGB) < 8 g/L requiring transfusion or a platelet count < 30 K/ul and requiring transfusion during or within 4 weeks after radiation.
SECONDARY OBJECTIVES:
I. To assess for early marrow changes in the vertebral bodies by magnetic resonance imaging (MRI) spine during radiation therapy (RT) by comparing one study MRI to the baseline pre-craniospinal radiation MRI.
II. To evaluate vertebral column growth (measured by MRI) over 5 years following vertebral body sparing cranio-spinal irradiation in pediatric patients.
III. To evaluate sitting height, height, weight and body mass index (BMI) annually.
IV. To evaluate for scoliosis.
V. To evaluate complete blood counts (CBC) over time in pediatric patients receiving vertebral body sparing cranio-spinal irradiation to evaluate vitamin D, calcium, and growth hormones annually.
VI. To monitor, both clinically and by MRI, for any abnormality in spinal curvature.
VII. To monitor disease free survival and patterns of relapse.
OUTLINE:
Patients undergo cranio-spinal irradiation using proton beam scanning with vertebral body sparing once daily (QD) 5 days per week in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and MRI on study.
After completion of study treatment patients are followed up at 4 weeks and then annually for 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorKevin Xinye Liu