Trial Outcomes & Findings for Alisertib and Fractionated Stereotactic Radiosurgery in Treating Patients With Recurrent High Grade Gliomas (NCT NCT02186509)

Last Updated: 2025-04-30

Results Overview

Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Up to 30 days after completion of radiation therapy

Results posted on

2025-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	Alisertib, Fractionated Stereotactic Radiosurgery CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 Participants CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 30 days after completion of radiation therapy

Defined as the dose at which \>= 2 patients experience dose-limiting toxicity, graded in severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Outcome measures

Outcome measures
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 Participants CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Maximum Tolerated Dose (MTD) of Alisertib	50 mg dose of Alisertib

SECONDARY outcome

Timeframe: Up to 5 years

95% confidence intervals will be computed. Response was defined by the Updated Response Assessment Criteria for High-Grade Gliomas: Response Assessment in Neuro-Oncology Work Group (RANO)

Outcome measures

Outcome measures
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 Participants CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Number of Participants With Complete or Partial Response	0 Participants

SECONDARY outcome

Timeframe: At 6 months

Estimated through the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 Participants CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Number of Participants With Progression Free Survival at 6 Months	6 Participants

SECONDARY outcome

Timeframe: At 6 months

Estimated through the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 Participants CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Number of Participants With Overall Survival at 6 Months	15 Participants

Adverse Events

Alisertib, Fractionated Stereotactic Radiosurgery

Serious events: 6 serious events

Other events: 17 other events

Deaths: 15 deaths

Serious adverse events

Serious adverse events
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 participants at risk CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Blood and lymphatic system disorders Leukopenia	11.8% 2/17 • 18 months from baseline
Blood and lymphatic system disorders Neutropenia	11.8% 2/17 • 18 months from baseline
Blood and lymphatic system disorders Lymphopenia	5.9% 1/17 • 18 months from baseline
Nervous system disorders Headache	5.9% 1/17 • 18 months from baseline

Other adverse events

Other adverse events
Measure	Alisertib, Fractionated Stereotactic Radiosurgery n=17 participants at risk CONCURRENT PHASE: Patients undergo fractionated stereotactic radiosurgery QD every weekday for 10 days and receive alisertib PO 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. Hyperfractionated radiation therapy: Undergo hyperfractionated radiation therapy Stereotactic radiosurgery: Undergo stereotactic radiosurgery Alisertib: Given PO Quality-of-life assessment: Ancillary studies
Blood and lymphatic system disorders Leukopenia	29.4% 5/17 • 18 months from baseline
Blood and lymphatic system disorders Neutropenia	5.9% 1/17 • 18 months from baseline
Blood and lymphatic system disorders Lymphopenia	41.2% 7/17 • 18 months from baseline
Blood and lymphatic system disorders Anemia	35.3% 6/17 • 18 months from baseline
Hepatobiliary disorders Transaminitis	11.8% 2/17 • 18 months from baseline
Blood and lymphatic system disorders Hyperlipidemia	23.5% 4/17 • 18 months from baseline
Hepatobiliary disorders Hyperbilirubinemia	17.6% 3/17 • 18 months from baseline
Metabolism and nutrition disorders Hyperglycemia	11.8% 2/17 • 18 months from baseline
Metabolism and nutrition disorders Hpocalcemia	29.4% 5/17 • 18 months from baseline
Metabolism and nutrition disorders Hyponatremia	11.8% 2/17 • 18 months from baseline
Nervous system disorders Focal seizure	11.8% 2/17 • 18 months from baseline
Nervous system disorders Headache	17.6% 3/17 • 18 months from baseline
Nervous system disorders Fall	5.9% 1/17 • 18 months from baseline
Nervous system disorders Dizziness	11.8% 2/17 • 18 months from baseline
Nervous system disorders Gait Disturbance	23.5% 4/17 • 18 months from baseline
General disorders Peripheral Edema	17.6% 3/17 • 18 months from baseline
Musculoskeletal and connective tissue disorders Muscle Weakness	23.5% 4/17 • 18 months from baseline
General disorders Fatigue	76.5% 13/17 • 18 months from baseline
Cardiac disorders Hypertension	17.6% 3/17 • 18 months from baseline
General disorders Alopecia	5.9% 1/17 • 18 months from baseline

Additional Information

Dr. Wenyin Shi

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215-955-6702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place