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Neuroprotective Effects of Lithium in Patients With Small Cell Lung Cancer Undergoing Radiation Therapy to the Brain

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ClinicalTrials.gov Identifier: NCT01553916
Recruitment Status : Completed
First Posted : March 14, 2012
Results First Posted : November 8, 2017
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Small Cell Lung Carcinoma
Interventions Drug: Lithium Carbonate
Radiation: Prophylactic cranial irradiation
Enrollment 19
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Period Title: Overall Study
Started 19
Completed 16
Not Completed 3
Reason Not Completed
Withdrawal by Subject             2
Pre-treatment MRI metastatic disease             1
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 19 participants
58
(49 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
12
  63.2%
Male
7
  36.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
 100.0%
1.Primary Outcome
Title Safety of Lithium Carbonate as Measured by Number of Patients in the Safety lead-in Who Experienced a Dose-limiting Toxicity (DLT)
Hide Description -Graded and described using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v 4. Safety will be defined as < 2 patients experiencing DLTs of the first 6 treated.
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
-Only patients enrolled in the safety lead-in were evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
2.Primary Outcome
Title Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.
  • The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: scores on a scale
20.0714  (8.29703)
3.Secondary Outcome
Title Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.
  • The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
11 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
20.2  (7.22342)
4.Secondary Outcome
Title Immediate Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Immediate Recall (HVLT-IR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The immediate recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them immediately. The list was read a second time followed by a second free recall trial. This was followed by a third reading and third free recall.
  • The words recalled for each trial were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
13 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
24.0  (4.89898)
5.Secondary Outcome
Title Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.
  • The words recalled were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
-8 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
8.6923  (2.89783)
6.Secondary Outcome
Title Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.
  • The words recalled were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
11 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.3  (1.56702)
7.Secondary Outcome
Title Delayed Recall Memory Deterioration as Measured by the Hopkins Verbal Learning Test - Delayed Recall (HVLT-DR) Total Score
Hide Description
  • The HVLT is a word learning test measuring episodic visual memory
  • The delayed recall memory deterioration test portion consists of 36 words split into 3 sections (animals, gemstones, places of shelter, types of birds, tools, items of clothing, kitchen utensils,weapons, and alcoholic beverages)
  • The words were read aloud and the participants was asked to freely recall them 20-25 minutes later.
  • The words recalled were recorded and a total recall score tallied (range: 0–36).
  • The higher the score the better the recall
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
13 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: scores on a scale
10.5  (0.83666)
8.Secondary Outcome
Title Changes in Quality-of-life as Measured by Overall Quality of Life Using the EORTC QLQ30
Hide Description
  • Assessed by comparing questionnaire test scores to baseline; European Organization for Research and Treatment of Cancer (EORTC) QLQ30 (global health/QOL, cognitive functioning, and fatigue scales)
  • 30 total questions with 28 questions having answers ranging from 1-4 with 1=not at all and 4= very much and 2 questions ranging from 0-7 with 1-very poor and 7=excellent
  • Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)
  • The higher the score the lower the quality of life
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 participants were not analyzed for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
45.0820  (7.4469)
9.Secondary Outcome
Title Changes in Quality-of-life as Measured by Overall Quality of Life Using the Total Score of the EORTC QLQ-BN20
Hide Description

Assessed by comparing questionnaire test scores to baseline; BN20 (future uncertainty and communications deficit scales)

  • 20 questions with answers ranging from 1-4 with 1=not at all and 4=very much
  • Raw scores will be transformed to a 100-point scale (0=lowest score, 100=highest score)
  • The higher the score the lower quality of life
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: scores on a scale
20.5514  (13.8067)
10.Secondary Outcome
Title Feasibility of Performing Serial Neurocognitive Testing and Quality of Life Exams as Measured by Number of Patients Who Complete the Neurocognitive Testing and Quality of Life Exams
Hide Description -Defined as at least 4 of 6 patients successfully completing pre-treatment and 3 month post-treatment testing
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
(1) participant is not evaluable as the participant did not start treatment due to pre-treatment MRI showing metastatic disease in spine.
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 18
Measure Type: Count of Participants
Unit of Measure: Participants
13
  72.2%
11.Secondary Outcome
Title Change in Hippocampal Morphology Following Lithium + PCI as Measured by Total Hippocampal Volume
Hide Description [Not Specified]
Time Frame Baseline through 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
  • 10 participants were evaluable for this outcome measure
  • Originally the outcome measure time frame was baseline through 12 months but there was insufficient data to statistically analyze the change in hippocampal morphology at 12 months due to the number of participants still alive for the 12 month scan.
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: cc
Baseline Number Analyzed 10 participants
6.13
(5.63 to 7.65)
3 months Number Analyzed 10 participants
6.08
(4.95 to 6.69)
12 months Number Analyzed 5 participants
6.34
(5.2 to 6.8)
12.Secondary Outcome
Title Number of Participants With Brain Metastases
Hide Description 1-year rate of brain metastases
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
7 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
2
  22.2%
13.Secondary Outcome
Title Number of Central Nervous System (CNS) Adverse Events
Hide Description Adverse events will be tabulated by type and grade using NCI CTCAE v 4.
Time Frame Through 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: CNS adverse events
Grade 1 28
Grade 2 6
Grade 3 2
14.Secondary Outcome
Title Rate of Overall Survival
Hide Description -Overall survival is defined as the time between date of on study and date of death due to any cause
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
7 participants were not evaluable for this outcome measure
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description:

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
5
  55.6%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Hide Arm/Group Description

Lithium carbonate 300 mg PO BID for 7 days prior to the start of prophylactic cranial irradiation (PCI) and will be continued during PCI.

PCI will be given at 2.5 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 25 Gy, starting on Day 8 after 7 days of lithium.

All-Cause Mortality
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Lithium Carbonate + Prophylactic Cranial Irradiation
Affected / at Risk (%)
Total   19/19 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  6/19 (31.58%) 
Red blood cell decrease  1  1/19 (5.26%) 
Ear and labyrinth disorders   
Ear pain  1  1/19 (5.26%) 
External ear pain  1  1/19 (5.26%) 
Hearing impaired  1  2/19 (10.53%) 
Tinnitus  1  1/19 (5.26%) 
Endocrine disorders   
Adrenal insufficiency  1  1/19 (5.26%) 
Eye disorders   
Blurred vision  1  2/19 (10.53%) 
Floaters  1  1/19 (5.26%) 
Gastrointestinal disorders   
Constipation  1  2/19 (10.53%) 
Diarrhea  1  2/19 (10.53%) 
Dyspepsia  1  2/19 (10.53%) 
Nausea  1  9/19 (47.37%) 
Vomiting  1  7/19 (36.84%) 
General disorders   
Chills  1  2/19 (10.53%) 
Edema face  1  1/19 (5.26%) 
Fatigue  1  11/19 (57.89%) 
Fever  1  2/19 (10.53%) 
Flu like symptoms  1  1/19 (5.26%) 
Gait disturbance  1  2/19 (10.53%) 
Malaise  1  1/19 (5.26%) 
Non-cardiac chest pain  1  1/19 (5.26%) 
Infections and infestations   
Bronchial infection  1  2/19 (10.53%) 
Lung infection  1  2/19 (10.53%) 
Sinusitis  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Dermatitis radiation  1  3/19 (15.79%) 
Fall  1  1/19 (5.26%) 
Spinal fracture  1  1/19 (5.26%) 
Investigations   
Alanine aminotransferase increased  1  3/19 (15.79%) 
Alkaline phosphatase increased  1  1/19 (5.26%) 
Aspartate aminotransferase increased  1  3/19 (15.79%) 
Creatinine increased  1  2/19 (10.53%) 
INR increased  1  1/19 (5.26%) 
Lymphocyte count decreased  1  9/19 (47.37%) 
Neutrophil count decreased  1  3/19 (15.79%) 
Platelet count decreased  1  2/19 (10.53%) 
Weight gain  1  1/19 (5.26%) 
Weight loss  1  3/19 (15.79%) 
White blood cell decreased  1  3/19 (15.79%) 
Metabolism and nutrition disorders   
Anorexia  1  7/19 (36.84%) 
Hypercalcemia  1  1/19 (5.26%) 
Hyperkalemia  1  2/19 (10.53%) 
Hypernatremia  1  1/19 (5.26%) 
Hypoalbuminemia  1  2/19 (10.53%) 
Hypocalcemia  1  2/19 (10.53%) 
Hypokalemia  1  2/19 (10.53%) 
Hyponatremia  1  3/19 (15.79%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/19 (21.05%) 
Back pain  1  3/19 (15.79%) 
Chest wall pain  1  1/19 (5.26%) 
Generalized muscle weakness  1  2/19 (10.53%) 
Myalgia  1  2/19 (10.53%) 
Neck pain  1  1/19 (5.26%) 
Other - sacroiliac pain  1  1/19 (5.26%) 
Other - right leg pain  1  1/19 (5.26%) 
Pain in extremity  1  1/19 (5.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Other - disease progression  1  1/19 (5.26%) 
Nervous system disorders   
Concentration impairment  1  1/19 (5.26%) 
Dizziness  1  9/19 (47.37%) 
Dysgeusia  1  5/19 (26.32%) 
Headache  1  10/19 (52.63%) 
Memory impairment  1  2/19 (10.53%) 
Nystagmus  1  1/19 (5.26%) 
Other - myoclonic jerk  1  1/19 (5.26%) 
Paresthesia  1  1/19 (5.26%) 
Peripheral motor neuropathy  1  1/19 (5.26%) 
Peripheral sensory neuropathy  1  2/19 (10.53%) 
Somnolence  1  1/19 (5.26%) 
Tremor  1  2/19 (10.53%) 
Psychiatric disorders   
Anxiety  1  2/19 (10.53%) 
Confusion  1  5/19 (26.32%) 
Depression  1  2/19 (10.53%) 
Renal and urinary disorders   
Acute kidney injury  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/19 (5.26%) 
Cough  1  2/19 (10.53%) 
Dyspnea  1  5/19 (26.32%) 
Laryngeal inflammation  1  1/19 (5.26%) 
Pneumonitis  1  1/19 (5.26%) 
Sore throat  1  1/19 (5.26%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  2/19 (10.53%) 
Rash acneiform  1  1/19 (5.26%) 
Skin hyperpigmentation  1  1/19 (5.26%) 
Vascular disorders   
Thromboembolic event  1  1/19 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Clifford Robinson, M.D.
Organization: Washington University School of Medicine
Phone: 314-362-4653
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01553916     History of Changes
Other Study ID Numbers: 201202073
First Submitted: March 12, 2012
First Posted: March 14, 2012
Results First Submitted: September 7, 2017
Results First Posted: November 8, 2017
Last Update Posted: July 4, 2018