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- GCC2020: Repurposing ibrutinib for chemo-immunotherapy in a phase 1b study of ibrutinib with indoximod plus metronomic cyclophosphamide and etoposide for pediatric patients with brain cancer
Clinical Trial
GCC2020: Repurposing ibrutinib for chemo-immunotherapy in a phase 1b study of ibrutinib with indoximod plus metronomic cyclophosphamide and etoposide for pediatric patients with brain cancer
This treatment protocol will enroll children and young adults ages 12 to 25 years with relapsed or refractory pediatric brain cancer that progressed after previous treatment with indoximod-based chemo-immunotherapy. The primary goal is that combining the study therapies will improve tumor response rate with a reduced or manageable toxicity (side effects). Patients will be treated with 28-day cycle regimen of 4 orals drugs: study drug ibrutinib, study drug indoximod, standard chemotherapy cyclophosphamide and standard chemotherapy etoposide. Patients may continue study therapy up to a maximum of 12 cycles as long as there is stable disease or response and no limiting toxicity.
Eligibility Criteria
- Brief inclusion criteria: Patients age 12 to 25 years with diagnosis of relapsed or refractory brain cancer Must be able to swallow pills Baseline lab results within parameters as outlined on page 35 of protocol Must have been treated previously with combination of indoximod and temozolomide Brief exclusion criteria: Patients who are unable to swallow pills Hypersensitivity to any drugs in the treatment plan Breastfeeding/pregnant women