Adult Glioblastoma Clinical Trial
Official title:
A Phase I/II Study of Local Field Irradiation and Temozolomide Followed by Continuous Infusion Plerixafor as an Upfront Therapy for Newly Diagnosed Glioblastoma GBM
This pilot phase I/II trial studies the side effects and best dose of plerixafor after radiation therapy and temozolomide and to see how well it works in treating patients with newly diagnosed high grade glioma. Plerixafor may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving plerixafor after radiation therapy and temozolomide may be an effective treatment for high grade glioma.
PRIMARY OBJECTIVES:
I. To assess the safety of using continuous infusion Plerixafor subsequent to irradiation in
patients with newly diagnosed glioblastoma multiforme (GBM).
II. To assess the efficacy of Plerixafor as measured by progression free survival at 6 months
(PFS6) from the start of irradiation.
OUTLINE: This is a phase I, dose-escalation study of plerixafor followed by a phase II study.
Within 4 weeks of surgery, patients undergo radiation therapy and receive temozolomide orally
(PO) over 42 days. Beginning 8 days prior to completion of chemoradiotherapy, patients
receive plerixafor intravenously (IV) continuously for 2-4 weeks. Patients also receive
temozolomide PO 5 days a month beginning 35 days after completion of radiation therapy.
After completion of study treatment, patients are followed up every 12 weeks for 5 years.
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