NCT01977677

Plerixafor After Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed High Grade Glioma

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Lawrence Recht · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Adult Ependymoblastoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Medulloblastoma
• Adult Mixed Glioma
• Adult Oligodendroglial Tumors
• Adult Pineoblastoma
• Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)

Interventions

Type	Name	Description
RADIATION	radiation therapy	Undergo radiation therapy
DRUG	temozolomide	Given PO
DRUG	plerixafor	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-11-01
• Completion: 2018-09-01
• First posted: 2013-11-07
• Last updated: 2018-10-23
• Results posted: 2018-07-03

Locations

1 site across 1 country: United States