This phase II trial studies how well whole brain radiation therapy works with standard temozolomide chemo-radiotherapy and plerixafor in treating patients with glioblastoma (brain tumor). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Plerixafor is a drug that may prevent recurrence of glioblastoma after radiation treatment. Giving whole brain radiation therapy with standard temozolomide chemo-radiotherapy and plerixafor may work better in treating patients with glioblastoma.
Additional locations may be listed on ClinicalTrials.gov for NCT03746080.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
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).
SECONDARY OBJECTIVES:
I. To assess the median survival of patients treated with continuous infusion plerixafor/WBRT.
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.
EXPLORATORY OBJECTIVE:
I. To assess the neurocognitive outcomes and patient-reported health-related quality of life after continuous infusion plerixafor/WBRT.
OUTLINE:
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 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 12 weeks for 5 years.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorLawrence Recht
