NCT02186509

Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas

Phase I Study of Alisertib With Concurrent Fractionated Stereotactic Radiation Treatment for Recurrent High Grade Gliomas

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of alisertib when combined with fractionated stereotactic radiosurgery in treating patients with high-grade gliomas that have returned after previous treatment with radiation therapy (recurrent). Alisertib may stop the growth of tumor cells by blocking an enzyme needed for the cells to divide. Radiation therapy uses high energy x rays to kill tumor cells. Stereotactic radiosurgery uses special positioning equipment to send a single high dose of radiation directly to the tumor and cause less damage to normal tissue. Delivering stereotactic radiosurgery over multiple doses (fractionation) may cause more damage to tumor tissue than normal tissue while maintaining the advantage of its accuracy.

Detailed description

PRIMARY OBJECTIVES: I. Evaluate the safety and tolerability of the study treatment. II. To determine the maximum tolerated dose (MTD) of daily oral alisertib when combined with fractionated stereotactic radiation treatment for recurrent high grade glioma. SECONDARY OBJECTIVES: I. To estimate 6 month progression free survival rate. II. To estimate the median time to progression. III. To estimate overall survival. IV. To estimate the impact on quality of life (QoL). OUTLINE: This is a dose-escalation study of alisertib. CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery once daily (QD) every weekday for 10 days and receive alisertib orally (PO) twice daily (BID) concurrently with radiation therapy for 10 days. MAINTENANCE PHASE: Patients receive alisertib PO BID on days 1-7. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 4-6 months thereafter.

Conditions

• Adult Anaplastic Astrocytoma
• Adult Anaplastic Ependymoma
• Adult Anaplastic Oligodendroglioma
• Adult Brain Stem Glioma
• Adult Diffuse Astrocytoma
• Adult Giant Cell Glioblastoma
• Adult Glioblastoma
• Adult Gliosarcoma
• Adult Mixed Glioma
• Adult Oligodendroglioma
• Adult Pilocytic Astrocytoma
• Adult Pineal Gland Astrocytoma
• Adult Subependymal Giant Cell Astrocytoma
• Recurrent Adult Brain Tumor

Interventions

Type	Name	Description
RADIATION	Hyperfractionated radiation therapy	Undergo hyperfractionated radiation therapy
RADIATION	Stereotactic radiosurgery	Undergo stereotactic radiosurgery
DRUG	Alisertib	Given PO
PROCEDURE	Quality-of-life assessment	Ancillary studies

Timeline

• Start date: 2015-01-30
• Primary completion: 2017-03-31
• Completion: 2018-12-31
• First posted: 2014-07-10
• Last updated: 2025-04-30
• Results posted: 2019-09-09

Locations

1 site across 1 country: United States