Sitagliptin

Sitagliptin, PO dose to be determined by Phase I dose de-escalation, cycle length 28 days. Treatment until progression.

Bevacizumab, IV, 10 mg/kg days 1 and 15 every 28 days, until progression.

In this Phase I trial, it is proposed that sitagliptin will be used to inhibit Myeloid Derived Suppressor Cells (MDSCs) in recurrent Glioblastoma (GBM). As this trial designed is for patients with recurrent GBM, patients will receive standard of care, bevacizumab, in addition to sitagliptin. The goal of this trial is to provide the proof of concept that suppressing MDSCs via sitagliptin is safe and feasible in patients with recurrent GBMs.

Sitagliptin, when combined with standard-of-care drug bevacizumab, is being tested to 1) find out if it is effective at treating gliomas that have returned or progressed after treatment, and 2) find out what the highest dose of sitagliptin is appropriate to give when combined with bevacizumab.

Registro actualizado en ClinicalTrials.gov →

• Subjects must have histologically or cytologically confirmed WHO grade 4 glioma for which disease recurrence/progression after first line therapy is diagnosed by the treating physician.
• Subjects must not have received sitagliptin or bevacizumab for this disease.
• Performance status: ECOG performance status 0-2
• Hemoglobin ≥ 9 g/dl
• Absolute neutrophil count ≥ 1,500/mcL

Criterios de inclusión tal como figuran en el registro, recortados. La lista completa, con las exclusiones, está en el registro actualizado.