This study plans to detect the presence of trastuzumab by mass spectroscopy in relapsed posterior fossa ependymoma (PFEPN) tumor specimen pre-treated with a single dose of intrathecal (IT) trastuzumab, as well as to evaluate toxicity of intrathecal trastuzumab in combination with subcutaneous (subQ) Granulocyte-macrophage colony-stimulating factor (GM-CSF) in children with relapsed PFEPN
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Administration of trastuzumab following subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Trastuzumab is a monoclonal antibody targeting HER2-positive cancers, commonly used in breast and gastric cancer treatment.
Combine trastuzumab, a monoclonal antibody targeting HER2-positive cancers, with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF functions as an immune system modulator, promoting the activation and proliferation of dendritic cells, macrophages, and granulocytes.
Children's Hospital Colorado
Aurora, Colorado, United States
Stratum 1: Detection of trastuzumab in tumor following IT administration
The presence of trastuzumab will be measured as a binary (yes/no) outcome.
Time frame: 2 weeks
Stratum 2: Determine the Maximum Tolerated Dose (MTD) for IT trastuzumab in combination with fixed doses of subQ GM-CSF
The estimated MTD would be the highest dose at which 0/3 or 1/6 subjects experience a Dose Limiting Toxicity (DLT).
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.