CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Alisertib +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02186509
NCT02186509Phase 1Completed

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

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Jul 10, 2014·Updated Apr 30, 2025

In Brief

A Phase 1 clinical trial evaluating Hyperfractionated radiation therapy, Stereotactic radiosurgery, and 2 other interventions for Adult Anaplastic Astrocytoma and 13 related conditions. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 10, 2014
Enrollment StartJan 30, 2015
Primary CompletionMar 31, 2017
Study CompletionDec 31, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.0 years ago

Interventions

Hyperfractionated radiation therapyradiation

Undergo hyperfractionated radiation therapy

Stereotactic radiosurgeryradiation

Undergo stereotactic radiosurgery

Alisertibdrug

Given PO

Quality-of-life assessmentprocedure

Ancillary studies