Trial Outcomes & Findings for Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer (NCT NCT00492089)

Results Overview

Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2014-05-09

Participant Flow

Recruitment Period: June 20, 2007 to December 07, 2009. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Of the 15 patients enrolled, four participants were excluded from the study.

Participant milestones

Participant milestones
Measure	Arm A: Bevacizumab Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks.	Crossover Arm B: Placebo First, Then Bevacizumab Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A.
First Intervention (6 Weeks) STARTED	5	6
First Intervention (6 Weeks) COMPLETED	5	6
First Intervention (6 Weeks) NOT COMPLETED	0	0
Second Intervention (6 Weeks) STARTED	5	6
Second Intervention (6 Weeks) COMPLETED	5	6
Second Intervention (6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Bevacizumab n=5 Participants Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks	Crossover Arm B: Placebo First, Then Bevacizumab n=6 Participants Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A	Total n=11 Participants Total of all reporting groups
Age, Continuous	43 years n=5 Participants	47 years n=7 Participants	47 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Analysis was conducted per protocol. The participants in the Crossover Arm were evaluated after receiving the Bevacizumab treatment as described in the arm description.

Change in magnetic resonance imaging (MRI) from baseline to evaluation at 6 weeks for participants where MRI changes are based on the size of edema (T2 FLAIR) and Gd-contrast enhancement (lesion diameter and perfusion/dynamic). A 25% reduction in T2 flair volume constitutes a response for study.

Outcome measures

Outcome measures
Measure	Arm A: Bevacizumab n=5 Participants Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks	Crossover Arm B: Placebo Then Bevacizumab n=6 Participants Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m\^2 IV as in Arm A
Number of Participants With Response ( > 25% Reduction in T2 Flair) From Baseline to Evaluation at 6 Weeks Post Treatment	5 participants	6 participants

Adverse Events

Bevacizumab

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bevacizumab n=11 participants at risk Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks	Placebo n=6 participants at risk First Intervention Placebo IV (only) every 3 weeks for two courses
Vascular disorders Thrombosis	18.2% 2/11 • Number of events 2 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
Gastrointestinal disorders Dysphagia	9.1% 1/11 • Number of events 2 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
Nervous system disorders Seizure	9.1% 1/11 • Number of events 1 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months

Other adverse events

Other adverse events
Measure	Bevacizumab n=11 participants at risk Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks	Placebo n=6 participants at risk First Intervention Placebo IV (only) every 3 weeks for two courses
Cardiac disorders Hypertension	36.4% 4/11 • Number of events 4 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
General disorders Fatigue	27.3% 3/11 • Number of events 3 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
Hepatobiliary disorders Elevated alanine aminotransferase (ALT)	18.2% 2/11 • Number of events 2 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
Gastrointestinal disorders Nausea	9.1% 1/11 • Number of events 1 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months
Blood and lymphatic system disorders Thrombocytopenia	9.1% 1/11 • Number of events 1 • 2 years and 9 months	0.00% 0/6 • 2 years and 9 months

Additional Information

Monica Loghin, MD / Assistant Professor

The University of Texas MD Anderson Cancer Center

Phone: K Hunter, RN 713-745-5769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60