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Low Dose Naltrexone for Glioma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01303835
Recruitment Status : Completed
First Posted : February 25, 2011
Results First Posted : June 26, 2015
Last Update Posted : July 17, 2015
Sponsor:
Information provided by (Responsible Party):
Katy Peters, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Malignant Glioma
Interventions Drug: LDN
Drug: Placebo
Enrollment 110
Recruitment Details  
Pre-assignment Details Patients were randomized to either low dose naltrexone (LDN) or placebo and were followed for 24 weeks. A patient is defined as completing the study if they completed the Quality of Life (QoL) assessments at 24 weeks.
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Randomized patients received 4.5 mg naltrexone to be taken every night before bed. Randomized patients received placebo to be taken every night before bed.
Period Title: Overall Study
Started 54 56
Completed 35 31
Not Completed 19 25
Arm/Group Title Naltrexone Placebo Total
Hide Arm/Group Description Randomized patients received 4.5 mg naltrexone to be taken every night before bed. Randomized patients received placebo to be taken every night before bed. Total of all reporting groups
Overall Number of Baseline Participants 54 56 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 56 participants 110 participants
55.6  (11.0) 56.7  (11.3) 56.2  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 56 participants 110 participants
Female
23
  42.6%
25
  44.6%
48
  43.6%
Male
31
  57.4%
31
  55.4%
62
  56.4%
1.Primary Outcome
Title Effects of Low-dose Naltrexone Versus Placebo on Change in Quality of Life (QoL) in High-grade Glioma Patients Undergoing Standard Chemoradiation From Baseline
Hide Description

The difference in QoL scores between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. QoL instruments included are listed below. Higher scores indicate more favorable outcomes unless otherwise indicated.

  • Functional Assessment of Cancer Therapy-Brain (FACT-Br) measures general QoL reflecting symptoms associated with brain malignancies (range 0-132)
  • Functional Assessment of Chronic Illness Therapy (FACIT-F) measures level of fatigue during patients' usual daily activities (range 0-52)
  • Epworth Sleepiness Scale measures level of daytime sleepiness. Note that higher scores indicate a greater level of sleepiness (range 0-24)
  • Medical Outcomes Survey (MOS) measures QoL including physical, mental and general health via 8 domains (range 0-100 for each domain)
  • Zung Self-Rating Depression Scale quantifies the depressed status of a patient. Lower scores indicate more favorable outcome (range 20-80) A difference
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis only includes those patients who completed both the initial QOL assessments and the 16 week QoL assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.
Arm/Group Title Low Dose Naltrexone (LDN) Placebo
Hide Arm/Group Description:
Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
Randomized patients received placebo to be taken every night before bed.
Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
FACT-Brain Trial Outcome Index (TOI) -3.73  (22.85) -6.06  (21.72)
FACIT-Fatigue -4.22  (11.07) -4.1  (13.41)
Epworth Sleepiness Scale 3.47  (4.37) 0.81  (3.45)
MOS - Physical Functioning -5.54  (34.41) -3.42  (29.75)
MOS - Role Limitations due to Physical Health 0  (51.71) 20.39  (41.86)
MOS - Role Limitations due to Emotional Issues 2.69  (49.31) 12.3  (56.11)
MOS - Energy/Fatigue -6.22  (29.8) -4.61  (29.76)
MOS - Emotional Well Being 3.5  (21.4) -1.89  (15.64)
MOS - Social Functioning 1.34  (32.38) 7.87  (41.57)
MOS - Pain 10.41  (27.12) 2.39  (24.92)
MOS - General Health -13.38  (17.8) -12.11  (19.82)
Zung Depression Scale 0.86  (11.15) 3.54  (8.48)
2.Secondary Outcome
Title Effects of Low-dose Naltrexone Versus Placebo on Change in Functional Capacity From Baseline
Hide Description Patients completed the 6-minute walk test (6MWT) at each QoL measurement assessment. The 6 minute walk test is a measure of functional capacity in which the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes is measured. The mean difference in distance traveled (in meters) between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in distance traveled, while a difference less than 0 indicates a decrease.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis only includes those patients who completed both the initial 6MWT assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.
Arm/Group Title Low Dose Naltrexone (LDN) Placebo
Hide Arm/Group Description:
Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
Randomized patients received placebo to be taken every night before bed.
Overall Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: Meters
13.43  (113.7) -6.42  (136.73)
3.Secondary Outcome
Title Effects of Low-dose Naltrexone Versus Placebo on Change in Neurocognitive Function From Baseline
Hide Description Patients completed neurocognitive testing at each QoL measurement assessment. Neurocognitive function was measured via a computerized neurocognitive test battery called CNS Vital Signs. The battery consists of 7 tests that assess verbal and visual memory, finger tapping, symbol digit coding, the Stroop Test, a test of shifting attention, and continuous performance. The battery provides scores over 9 domains with higher scores indicating better performance. Scores were normalized to a standard score mean of 100 and standard deviation of 15 using a normative sample. The mean difference in score in each domain between the 3rd QoL measurement (approximately 16 weeks from initial assessment) and the initial baseline assessment are reported. A difference greater than 0 indicates an increase in mean score, while a difference less than 0 indicates a decrease in mean score.
Time Frame Baseline and 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis only includes those patients who completed both the initial CNS Vital Signs assessments and the 16 week assessments, and thus number of participants may not match those reported in the participant flow module, which reports number of participants completing the trial at 24 weeks.
Arm/Group Title Low Dose Naltrexone (LDN) Placebo
Hide Arm/Group Description:
Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
Randomized patients received placebo to be taken every night before bed.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Memory -5.38  (24.03) -0.24  (17.63)
Processing Speed -0.71  (24.72) 7.32  (19.17)
Reaction Time -7.24  (29.61) -8.64  (17.03)
Verbal Memory -0.1  (28.22) 2  (17.29)
Visual Memory -8.38  (19.05) -2.24  (19.32)
Cognitive Flexibility 3.62  (23.14) 7.44  (22.12)
Complex Attention 7.33  (32.07) 6.24  (18.84)
Psychomotor Speed -0.76  (13) 4.72  (11.6)
Executive Functioning 3.9  (23.17) 7.56  (22.87)
Time Frame 24 weeks
Adverse Event Reporting Description The adverse events were gathered in Common Terminology Criteria for Adverse Events v.4.0
 
Arm/Group Title Naltrexone Placebo
Hide Arm/Group Description Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed. Randomized patients received placebo to be taken every night before bed.
All-Cause Mortality
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/54 (22.22%)   17/56 (30.36%) 
Blood and lymphatic system disorders     
Anemia † 1  0/54 (0.00%)  1/56 (1.79%) 
Cardiac disorders     
Atrial fibrillation † 1  0/54 (0.00%)  1/56 (1.79%) 
Sinus tachycardia † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastrointestinal disorders     
Dysphagia † 1  0/54 (0.00%)  1/56 (1.79%) 
Nausea † 1  1/54 (1.85%)  0/56 (0.00%) 
Pancreatitis † 1  0/54 (0.00%)  1/56 (1.79%) 
Vomiting † 1  1/54 (1.85%)  0/56 (0.00%) 
General disorders     
Edema face † 1  1/54 (1.85%)  1/56 (1.79%) 
Edema limbs † 1  1/54 (1.85%)  1/56 (1.79%) 
Fatigue † 1  1/54 (1.85%)  0/56 (0.00%) 
Fever † 1  2/54 (3.70%)  1/56 (1.79%) 
Infections and infestations     
Encephalitis infection † 1  0/54 (0.00%)  1/56 (1.79%) 
Lung infection † 1  0/54 (0.00%)  3/56 (5.36%) 
Mucosal infection † 1  0/54 (0.00%)  1/56 (1.79%) 
Rash pustular † 1  0/54 (0.00%)  1/56 (1.79%) 
Sepsis † 1  0/54 (0.00%)  1/56 (1.79%) 
Urinary tract infection † 1  1/54 (1.85%)  0/56 (0.00%) 
Investigations     
Neutrophil count decreased † 1  1/54 (1.85%)  2/56 (3.57%) 
Platelet count decreased † 1  2/54 (3.70%)  2/56 (3.57%) 
White blood cell decreased † 1  2/54 (3.70%)  2/56 (3.57%) 
Metabolism and nutrition disorders     
Dehydration † 1  3/54 (5.56%)  0/56 (0.00%) 
Hyponatremia † 1  0/54 (0.00%)  2/56 (3.57%) 
Musculoskeletal and connective tissue disorders     
Chest wall pain † 1  0/54 (0.00%)  1/56 (1.79%) 
Generalized muscle weakness † 1  0/54 (0.00%)  1/56 (1.79%) 
Muscle weakness left-sided † 1  1/54 (1.85%)  0/56 (0.00%) 
Nervous system disorders     
Dysphasia † 1  0/54 (0.00%)  1/56 (1.79%) 
Edema cerebral † 1  1/54 (1.85%)  0/56 (0.00%) 
Encephalopathy † 1  0/54 (0.00%)  2/56 (3.57%) 
Headache † 1  3/54 (5.56%)  1/56 (1.79%) 
Pyramidal tract syndrome † 1  0/54 (0.00%)  1/56 (1.79%) 
Seizure † 1  1/54 (1.85%)  2/56 (3.57%) 
Somnolence † 1  0/54 (0.00%)  1/56 (1.79%) 
Psychiatric disorders     
Confusion † 1  2/54 (3.70%)  0/56 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea † 1  0/54 (0.00%)  2/56 (3.57%) 
Hypoxia † 1  0/54 (0.00%)  1/56 (1.79%) 
Pneumonitis † 1  0/54 (0.00%)  2/56 (3.57%) 
Pulmonary edema † 1  1/54 (1.85%)  0/56 (0.00%) 
Vascular disorders     
Hypotension † 1  0/54 (0.00%)  1/56 (1.79%) 
Thromboembolic event † 1  2/54 (3.70%)  7/56 (12.50%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Naltrexone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   51/54 (94.44%)   54/56 (96.43%) 
Blood and lymphatic system disorders     
Anemia † 1  18/54 (33.33%)  25/56 (44.64%) 
Cardiac disorders     
Chest pain - cardiac † 1  1/54 (1.85%)  0/56 (0.00%) 
Conduction disorder † 1  1/54 (1.85%)  0/56 (0.00%) 
Sinus bradycardia † 1  0/54 (0.00%)  1/56 (1.79%) 
Ventricular tachycardia † 1  0/54 (0.00%)  1/56 (1.79%) 
Eye disorders     
Blurred vision † 1  2/54 (3.70%)  5/56 (8.93%) 
Eye disorders - Other, specify: VISUAL FIELD CUT IN BOTH LOWER QUADRANTS † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastrointestinal disorders     
Abdominal pain † 1  1/54 (1.85%)  0/56 (0.00%) 
Constipation † 1  20/54 (37.04%)  20/56 (35.71%) 
Diarrhea † 1  2/54 (3.70%)  6/56 (10.71%) 
Dyspepsia † 1  1/54 (1.85%)  2/56 (3.57%) 
Dysphagia † 1  0/54 (0.00%)  1/56 (1.79%) 
Fecal incontinence † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastritis † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastroesophageal reflux disease † 1  2/54 (3.70%)  0/56 (0.00%) 
Gastrointestinal disorders - Other, specify: CHIPPED TOOTH † 1  1/54 (1.85%)  0/56 (0.00%) 
Gastrointestinal disorders - Other, specify: DIVERTICULITIS † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastrointestinal disorders - Other, specify: DIVERTICULITIS BASELINE † 1  0/54 (0.00%)  1/56 (1.79%) 
Gastrointestinal disorders - Other, specify: GI BUG † 1  1/54 (1.85%)  0/56 (0.00%) 
Hemorrhoids † 1  1/54 (1.85%)  0/56 (0.00%) 
Ileal obstruction † 1  0/54 (0.00%)  1/56 (1.79%) 
Mucositis oral † 1  3/54 (5.56%)  6/56 (10.71%) 
Nausea † 1  15/54 (27.78%)  19/56 (33.93%) 
Vomiting † 1  6/54 (11.11%)  4/56 (7.14%) 
General disorders     
Chills † 1  1/54 (1.85%)  0/56 (0.00%) 
Edema face † 1  0/54 (0.00%)  1/56 (1.79%) 
Edema limbs † 1  5/54 (9.26%)  2/56 (3.57%) 
Fatigue † 1  36/54 (66.67%)  35/56 (62.50%) 
Fever † 1  3/54 (5.56%)  2/56 (3.57%) 
Flu like symptoms † 1  1/54 (1.85%)  0/56 (0.00%) 
Irritability † 1  0/54 (0.00%)  1/56 (1.79%) 
Non-cardiac chest pain † 1  1/54 (1.85%)  0/56 (0.00%) 
Pain † 1  0/54 (0.00%)  1/56 (1.79%) 
Hepatobiliary disorders     
Cholecystitis † 1  1/54 (1.85%)  1/56 (1.79%) 
Immune system disorders     
Allergic reaction † 1  0/54 (0.00%)  2/56 (3.57%) 
Infections and infestations     
Abdominal infection † 1  0/54 (0.00%)  1/56 (1.79%) 
Infections and infestations - Other, specify: FLU † 1  0/54 (0.00%)  1/56 (1.79%) 
Infections and infestations - Other, specify: H-PYLORI † 1  1/54 (1.85%)  0/56 (0.00%) 
Infections and infestations - Other, specify: LLE CELLULITIS † 1  1/54 (1.85%)  0/56 (0.00%) 
Infections and infestations - Other, specify: LYME'S DX † 1  1/54 (1.85%)  0/56 (0.00%) 
Infections and infestations - Other, specify: SHINGLES † 1  1/54 (1.85%)  1/56 (1.79%) 
Otitis externa † 1  0/54 (0.00%)  1/56 (1.79%) 
Papulopustular rash † 1  1/54 (1.85%)  0/56 (0.00%) 
Sinusitis † 1  0/54 (0.00%)  2/56 (3.57%) 
Upper respiratory infection † 1  4/54 (7.41%)  1/56 (1.79%) 
Urinary tract infection † 1  2/54 (3.70%)  2/56 (3.57%) 
Wound infection † 1  0/54 (0.00%)  1/56 (1.79%) 
Injury, poisoning and procedural complications     
Fall † 1  2/54 (3.70%)  0/56 (0.00%) 
Radiation recall reaction (dermatologic) † 1  1/54 (1.85%)  0/56 (0.00%) 
Wound complication † 1  0/54 (0.00%)  2/56 (3.57%) 
Investigations     
Alanine aminotransferase increased † 1  16/54 (29.63%)  19/56 (33.93%) 
Alkaline phosphatase increased † 1  2/54 (3.70%)  3/56 (5.36%) 
Aspartate aminotransferase increased † 1  16/54 (29.63%)  14/56 (25.00%) 
Blood bilirubin increased † 1  6/54 (11.11%)  8/56 (14.29%) 
Creatinine increased † 1  5/54 (9.26%)  5/56 (8.93%) 
Lipase increased † 1  0/54 (0.00%)  1/56 (1.79%) 
Lymphocyte count decreased † 1  17/54 (31.48%)  20/56 (35.71%) 
Neutrophil count decreased † 1  9/54 (16.67%)  18/56 (32.14%) 
Platelet count decreased † 1  29/54 (53.70%)  31/56 (55.36%) 
Weight gain † 1  1/54 (1.85%)  0/56 (0.00%) 
Weight loss † 1  5/54 (9.26%)  2/56 (3.57%) 
White blood cell decreased † 1  18/54 (33.33%)  23/56 (41.07%) 
Metabolism and nutrition disorders     
Anorexia † 1  8/54 (14.81%)  10/56 (17.86%) 
Dehydration † 1  0/54 (0.00%)  1/56 (1.79%) 
Hyperglycemia † 1  32/54 (59.26%)  28/56 (50.00%) 
Hyperkalemia † 1  3/54 (5.56%)  2/56 (3.57%) 
Hypernatremia † 1  5/54 (9.26%)  3/56 (5.36%) 
Hypoalbuminemia † 1  9/54 (16.67%)  12/56 (21.43%) 
Hypocalcemia † 1  16/54 (29.63%)  10/56 (17.86%) 
Hypoglycemia † 1  3/54 (5.56%)  7/56 (12.50%) 
Hypokalemia † 1  15/54 (27.78%)  10/56 (17.86%) 
Hyponatremia † 1  10/54 (18.52%)  14/56 (25.00%) 
Metabolism and nutrition disorders - Other, specify: PHOSPHORUS ELEVATED † 1  0/54 (0.00%)  1/56 (1.79%) 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  2/54 (3.70%)  3/56 (5.36%) 
Arthritis † 1  0/54 (0.00%)  1/56 (1.79%) 
Back pain † 1  1/54 (1.85%)  1/56 (1.79%) 
Buttock pain † 1  0/54 (0.00%)  1/56 (1.79%) 
Chest wall pain † 1  1/54 (1.85%)  0/56 (0.00%) 
Generalized muscle weakness † 1  2/54 (3.70%)  1/56 (1.79%) 
Muscle weakness left-sided † 1  2/54 (3.70%)  0/56 (0.00%) 
Muscle weakness lower limb † 1  1/54 (1.85%)  1/56 (1.79%) 
Muscle weakness right-sided † 1  2/54 (3.70%)  0/56 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN FEET † 1  1/54 (1.85%)  0/56 (0.00%) 
Musculoskeletal and connective tissue disorder - Other, specify: CRAMPS IN LEGS † 1  0/54 (0.00%)  1/56 (1.79%) 
Musculoskeletal and connective tissue disorder - Other, specify: JOINT AND MUSCLE PAIN † 1  0/54 (0.00%)  1/56 (1.79%) 
Myalgia † 1  1/54 (1.85%)  1/56 (1.79%) 
Myositis † 1  1/54 (1.85%)  0/56 (0.00%) 
Neck pain † 1  1/54 (1.85%)  0/56 (0.00%) 
Pain in extremity † 1  1/54 (1.85%)  2/56 (3.57%) 
Nervous system disorders     
Ataxia † 1  1/54 (1.85%)  0/56 (0.00%) 
Cerebrospinal fluid leakage † 1  1/54 (1.85%)  0/56 (0.00%) 
Cognitive disturbance † 1  1/54 (1.85%)  0/56 (0.00%) 
Dysgeusia † 1  3/54 (5.56%)  4/56 (7.14%) 
Dysphasia † 1  1/54 (1.85%)  0/56 (0.00%) 
Edema cerebral † 1  0/54 (0.00%)  1/56 (1.79%) 
Headache † 1  8/54 (14.81%)  15/56 (26.79%) 
Hypersomnia † 1  1/54 (1.85%)  0/56 (0.00%) 
Intracranial hemorrhage † 1  0/54 (0.00%)  1/56 (1.79%) 
Memory impairment † 1  3/54 (5.56%)  0/56 (0.00%) 
Nervous system disorders - Other, specify: BASELINE L HEMIPARESIS † 1  1/54 (1.85%)  0/56 (0.00%) 
Nervous system disorders - Other, specify: DECREASED GRIP STRENGTH IN R HAND † 1  1/54 (1.85%)  0/56 (0.00%) 
Nervous system disorders - Other, specify: GAIT DISTURBANCE † 1  0/54 (0.00%)  1/56 (1.79%) 
Nervous system disorders - Other, specify: L HEMIPARESIS † 1  1/54 (1.85%)  1/56 (1.79%) 
Nervous system disorders - Other, specify: LE WEAKNESS † 1  1/54 (1.85%)  0/56 (0.00%) 
Paresthesia † 1  2/54 (3.70%)  0/56 (0.00%) 
Peripheral sensory neuropathy † 1  1/54 (1.85%)  0/56 (0.00%) 
Pyramidal tract syndrome † 1  0/54 (0.00%)  1/56 (1.79%) 
Seizure † 1  6/54 (11.11%)  3/56 (5.36%) 
Tremor † 1  4/54 (7.41%)  2/56 (3.57%) 
Psychiatric disorders     
Agitation † 1  1/54 (1.85%)  0/56 (0.00%) 
Anxiety † 1  4/54 (7.41%)  0/56 (0.00%) 
Confusion † 1  1/54 (1.85%)  0/56 (0.00%) 
Depression † 1  2/54 (3.70%)  2/56 (3.57%) 
Insomnia † 1  7/54 (12.96%)  1/56 (1.79%) 
Psychiatric disorders - Other, specify † 1  4/54 (7.41%)  1/56 (1.79%) 
Renal and urinary disorders     
Acute kidney injury † 1  2/54 (3.70%)  2/56 (3.57%) 
Proteinuria † 1  3/54 (5.56%)  5/56 (8.93%) 
Renal calculi † 1  1/54 (1.85%)  0/56 (0.00%) 
Urinary incontinence † 1  1/54 (1.85%)  1/56 (1.79%) 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis † 1  1/54 (1.85%)  1/56 (1.79%) 
Cough † 1  1/54 (1.85%)  3/56 (5.36%) 
Dyspnea † 1  5/54 (9.26%)  0/56 (0.00%) 
Epistaxis † 1  2/54 (3.70%)  3/56 (5.36%) 
Hoarseness † 1  5/54 (9.26%)  2/56 (3.57%) 
Nasal congestion † 1  1/54 (1.85%)  0/56 (0.00%) 
Pneumonitis † 1  1/54 (1.85%)  0/56 (0.00%) 
Postnasal drip † 1  6/54 (11.11%)  7/56 (12.50%) 
Sore throat † 1  1/54 (1.85%)  0/56 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia † 1  1/54 (1.85%)  2/56 (3.57%) 
Dry skin † 1  2/54 (3.70%)  2/56 (3.57%) 
Pruritus † 1  4/54 (7.41%)  0/56 (0.00%) 
Rash acneiform † 1  1/54 (1.85%)  2/56 (3.57%) 
Rash maculo-papular † 1  4/54 (7.41%)  3/56 (5.36%) 
Skin and subcutaneous tissue disorders - Other, specify: DERMATITIS AT WOUND SITE † 1  0/54 (0.00%)  1/56 (1.79%) 
Skin and subcutaneous tissue disorders-MACULAR ERRYTHEMATOUS, BACK AND ABDOMEN † 1  1/54 (1.85%)  0/56 (0.00%) 
Vascular disorders     
Hematoma † 1  0/54 (0.00%)  1/56 (1.79%) 
Hypertension † 1  3/54 (5.56%)  2/56 (3.57%) 
Hypotension † 1  0/54 (0.00%)  2/56 (3.57%) 
Thromboembolic event † 1  5/54 (9.26%)  1/56 (1.79%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
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Name/Title: Katherine B. Peters, MD, PhD
Organization: Duke University Medical Center, The Preston Robert Tisch Brain Tumor Center
Phone: (919) 684-6173
EMail: katherine.peters@duke.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Katy Peters, Duke University
ClinicalTrials.gov Identifier: NCT01303835    
Other Study ID Numbers: Pro00027661
First Submitted: February 23, 2011
First Posted: February 25, 2011
Results First Submitted: May 8, 2015
Results First Posted: June 26, 2015
Last Update Posted: July 17, 2015