- I. To assess the 6 month progression-free survival (PFS) (post initiation of radiation) of
continuous infusion plerixafor beginning one week prior to the end of concurrent chemotherapy
with temozolomide and a modified radiation regimen that includes a component of whole brain
radiation therapy (WBRT) in patients with newly diagnosed glioblastoma (GBM).
- I. To assess the median survival of patients treated with continuous infusion
- II. To assess the toxicities both short and long term of continuous infusion plerixafor/WBRT.
- III. To assess the patterns of failure (in and out of irradiated brain field, out of brain)
of continuous infusion plerixafor/WBRT.
After completion maximal safe surgical resection, patients undergo radiation therapy for 42
days, initiating whole brain radiation therapy at day 21 (dose 16 of radiation therapy) and
receive temozolomide daily on days 1-42. Beginning 7 days before the completion of whole
brain radiation therapy, patients receive plerixafor by continuous infusion on days 1-28.
Beginning 1 week after completion of plerixafor infusion and 35 days after completion of
whole brain radiation therapy, patients receive temozolomide monthly for 6-12 courses in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for adverse events for 30 days
after the last dose of Plerixafor and then every 12 weeks for 5 years for survival follow-up.