Early-Phase Study to Assess Inhibitor Ribociclib in Patients With Recurrent Glioblastoma or Anaplastic Glioma
Status:
Unknown status
Trial end date:
2020-01-01
Target enrollment:
Participant gender:
Summary
This is a single-institution, open-label, early-phase study to assess the ability of
ribociclib (LEE011) to inhibit CDK4/CDK6/Rb/E2F signaling and cell proliferation/viability in
core and infiltrating tumor tissues obtained from patients with recurrent glioblastoma or
anaplastic glioma compared to the baseline/primary pathologic tumor specimen. Abundant
preclinical evidence indicates that Rb-deficient cancer cells are resistant to CDK4/6
inhibition and ongoing trials with CDK4/6 inhibitors exclude patients with Rb-deficient
tumors. The investigators will evaluate 10 patients with Rb-positive glioblastoma or
anaplastic glioma in this study. Given that a minority of glioblastomas ha Rb loss the
investigators anticipate enrolling a maximum of 20 patients, to meet our goal of 10 patients
with Rb-positive tumors.