drugset / Trial / NCT02186509

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

NCT02186509

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-01-30
Primary completion
2017-03-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Alisertib Small molecule 20 mg Oral
Subject Alisertib Small molecule 30 mg Oral
Subject Alisertib Small molecule 40 mg Oral
Subject Alisertib Small molecule 50 mg Oral