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Trial record 32 of 283 for:    Tumor infiltrating lymphocytes

Evaluation of Circulating T Cells and Tumor Infiltrating Lymphocytes (TILs) During / After Pre-Surgery Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) (TOP1201 IPI)

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ClinicalTrials.gov Identifier: NCT01820754
Recruitment Status : Completed
First Posted : March 29, 2013
Results First Posted : May 22, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non Small Cell Lung Cancer
Interventions Drug: Ipilimumab
Drug: Paclitaxel, Cisplatin, Carboplatin
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ipilimumab
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Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin Area Under Curve (AUC) 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Ipilimumab
Hide Arm/Group Description

Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
65.3  (8.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
12
  50.0%
Male
12
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
19
  79.2%
Unknown or Not Reported
5
  20.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  20.8%
White
19
  79.2%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Subjects With Detectable Circulating T Cells After Treatment
Hide Description The primary objective of this trial is to determine the percentage of early stage lung cancer patients with detectable circulating T cells specific against tumor-associated antigen (TAA) after receiving platinum based neoadjuvant chemotherapy plus ipilimumab before surgery. Based on Duke intracellular cytokine staining (ICS) assessments over the past 8 years, "detectable" circulating T cells with specificity against TAA are defined as a CD8, CD4, and double positive (DP) (CD4+CD8+) lymphocyte percentage of ≥ 0.05% with each value also being at least twice that of the background unstimulated control value.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat. Note that the 16.7% of patients that had detectable T-cell responses also had responses at baseline
Arm/Group Title Ipilimumab
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Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: Percentage of participants
16.7
2.Secondary Outcome
Title Feasibility and Tolerability of Neoadjuvant Chemotherapy Plus Ipilimumab and Surgery
Hide Description

Number of subjects experiencing any of the criteria listed below:

  • Number of subjects receiving 3 doses of preoperative therapy
  • Number of subjects undergoing surgical exploration within 42 days of day 1 of the last cycle of neoadjuvant chemotherapy
  • Number of subjects undergoing lobectomy having surgery-related mortality
  • Number of subjects experiencing dose-limiting toxicity (DLT) during neoadjuvant therapy. DLT will be defined as treatment-related: ≥ Grade 4 hematologic toxicity (excluding neutropenia without fever or infection) or ≥ Grade 3 non-hematologic toxicity (excluding fatigue, nausea, vomiting, peripheral neuropathy, chemotherapy infusion reaction to carboplatin or paclitaxel)
Time Frame 6 months
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Hide Analysis Population Description
Intent to treat
Arm/Group Title Ipilimumab
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Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
Patients receiving 3 cycles
24
 100.0%
Patients undergoing surgical exploration
13
  54.2%
Patients undergoing lobectomy
11
  45.8%
Patients experiencing a DLT
3
  12.5%
3.Secondary Outcome
Title Median Disease-Free Survival
Hide Description Disease-free survival (DFS) is defined as the time from surgical resection to disease recurrence (first disease recurrence or death, whichever comes first) after surgery. Patients alive who had not recurred as of the last follow-up had DFS censored at the last follow-up date. The Kaplan-Meier estimator will be used to estimate median DFS and its 95% confidence interval.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients were no longer followed for recurrence following surgery, so this outcome was not captured
Arm/Group Title Ipilimumab
Hide Arm/Group Description:

Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Number of Subjects Experiencing a Metastasis by Site of Metastasis
Hide Description Number of patients experiencing a metastasis between baseline and cycle 3
Time Frame 3 months
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Hide Analysis Population Description
Intent to treat
Arm/Group Title Ipilimumab
Hide Arm/Group Description:

Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
1
   4.2%
5.Secondary Outcome
Title Patterns of Pathologic Response and Response Evaluation Criteria in Solid Tumor (RECIST) Response
Hide Description

Within each category of RECIST response [partial response (PR), stable disease (SD), progressive disease (PD)], the number of subjects experiencing a pathologic complete response, pathologic partial response, and no pathologic response. RECIST evaluation will be conducted after completion of neoadjuvant therapy. Pathologic response will be evaluated in the resected tumor as follows:

  • No Pathologic Response: No evidence of cell death or tumor necrosis
  • Pathologic Partial Response: ≥30% tumor necrosis or cell death
  • Pathologic Complete Response: No evidence of viable tumor in surgical specimen (includes lung tissue and dissected lymph nodes)
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Note: pathological response was not captured for study participants. Therefore, the RECIST responses for patients at neoadjuvant month 3 are reported.
Arm/Group Title Ipilimumab
Hide Arm/Group Description:

Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

Overall Number of Participants Analyzed 24
Measure Type: Count of Participants
Unit of Measure: Participants
PR
14
  58.3%
SD
8
  33.3%
PD
2
   8.3%
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ipilimumab
Hide Arm/Group Description

Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes Adjuvant: Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery) Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Ipilimumab: Neoadjuvant: Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes

Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)

Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses

Paclitaxel, Cisplatin, Carboplatin: Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)

Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin

All-Cause Mortality
Ipilimumab
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ipilimumab
Affected / at Risk (%)
Total   6/24 (25.00%) 
Gastrointestinal disorders   
Abdominal pain  1  1/24 (4.17%) 
Diarrhea  1  1/24 (4.17%) 
Dysphagia  1  1/24 (4.17%) 
Rectal hemorrhage  1  1/24 (4.17%) 
Infections and infestations   
Lung infection  1  1/24 (4.17%) 
Investigations   
Neutrophil count decreased  1  1/24 (4.17%) 
Metabolism and nutrition disorders   
Dehydration  1  2/24 (8.33%) 
Renal and urinary disorders   
Acute kidney injury  1  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/24 (4.17%) 
Laryngeal hemorrhage  1  1/24 (4.17%) 
Vascular disorders   
Thromboembolic event  1  2/24 (8.33%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ipilimumab
Affected / at Risk (%)
Total   24/24 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  21/24 (87.50%) 
Cardiac disorders   
Atrial fibrillation  1  2/24 (8.33%) 
Cardiac disorders - Other, specify: PACS, PATS  1  1/24 (4.17%) 
Chest pain - cardiac  1  2/24 (8.33%) 
Palpitations  1  1/24 (4.17%) 
Sinus tachycardia  1  2/24 (8.33%) 
Supraventricular tachycardia  1  1/24 (4.17%) 
Ear and labyrinth disorders   
Ear pain  1  1/24 (4.17%) 
Endocrine disorders   
Adrenal insufficiency  1  4/24 (16.67%) 
Endocrine disorders - Other, specify: NIGHT SWEATS  1  1/24 (4.17%) 
Eye disorders   
Eye disorders - Other, specify: AURA WHEN READING THIS MORNING  1  1/24 (4.17%) 
Gastrointestinal disorders   
Abdominal pain  1  3/24 (12.50%) 
Cheilitis  1  1/24 (4.17%) 
Colitis  1  3/24 (12.50%) 
Constipation  1  8/24 (33.33%) 
Diarrhea  1  9/24 (37.50%) 
Dry mouth  1  1/24 (4.17%) 
Dyspepsia  1  2/24 (8.33%) 
Dysphagia  1  2/24 (8.33%) 
Gastritis  1  3/24 (12.50%) 
Gastroesophageal reflux disease  1  2/24 (8.33%) 
Gastrointestinal disorders - Other, specify: GAS  1  1/24 (4.17%) 
Gastrointestinal disorders - Other, specify: GASSY, BURPING  1  1/24 (4.17%) 
Hemorrhoids  1  1/24 (4.17%) 
Mucositis oral  1  5/24 (20.83%) 
Nausea  1  14/24 (58.33%) 
Oral pain  1  2/24 (8.33%) 
Rectal pain  1  1/24 (4.17%) 
Vomiting  1  6/24 (25.00%) 
General disorders   
Chills  1  4/24 (16.67%) 
Edema limbs  1  3/24 (12.50%) 
Fatigue  1  20/24 (83.33%) 
Fever  1  4/24 (16.67%) 
Flu like symptoms  1  1/24 (4.17%) 
General disorders and administration site conditions - Other, specify: FAILURE TO THRIVE  1  1/24 (4.17%) 
General disorders and administration site conditions - Other, specify: SWEATS X 2 WKS  1  1/24 (4.17%) 
Infusion related reaction  1  2/24 (8.33%) 
Malaise  1  1/24 (4.17%) 
Non-cardiac chest pain  1  3/24 (12.50%) 
Pain  1  6/24 (25.00%) 
Infections and infestations   
Infections and infestations - Other, specify: FOLLICULITIS  1  1/24 (4.17%) 
Infections and infestations - Other, specify: ORAL CANDIDIASIS  1  1/24 (4.17%) 
Infections and infestations - Other, specify: PNA ON CXR  1  1/24 (4.17%) 
Infections and infestations - Other, specify: URI/AUGMENTIN  1  1/24 (4.17%) 
Infections and infestations - Other, specify: URI/LEVAQUIN  1  1/24 (4.17%) 
Infections and infestations - Other, specify: UTI ABX X 10 D  1  1/24 (4.17%) 
Lip infection  1  1/24 (4.17%) 
Nail infection  1  1/24 (4.17%) 
Sinusitis  1  1/24 (4.17%) 
Urinary tract infection  1  2/24 (8.33%) 
Injury, poisoning and procedural complications   
Fall  1  2/24 (8.33%) 
Postoperative thoracic procedure complication  1  3/24 (12.50%) 
Wound dehiscence  1  1/24 (4.17%) 
Investigations   
Alanine aminotransferase increased  1  2/24 (8.33%) 
Alkaline phosphatase increased  1  1/24 (4.17%) 
Aspartate aminotransferase increased  1  3/24 (12.50%) 
Creatinine increased  1  3/24 (12.50%) 
INR increased  1  2/24 (8.33%) 
Neutrophil count decreased  1  5/24 (20.83%) 
Platelet count decreased  1  10/24 (41.67%) 
Weight loss  1  3/24 (12.50%) 
White blood cell decreased  1  2/24 (8.33%) 
Metabolism and nutrition disorders   
Anorexia  1  10/24 (41.67%) 
Dehydration  1  6/24 (25.00%) 
Hyperglycemia  1  7/24 (29.17%) 
Hyperkalemia  1  1/24 (4.17%) 
Hyperuricemia  1  2/24 (8.33%) 
Hypoalbuminemia  1  8/24 (33.33%) 
Hypocalcemia  1  2/24 (8.33%) 
Hypokalemia  1  8/24 (33.33%) 
Hypomagnesemia  1  8/24 (33.33%) 
Hyponatremia  1  8/24 (33.33%) 
Hypophosphatemia  1  1/24 (4.17%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  14/24 (58.33%) 
Bone pain  1  1/24 (4.17%) 
Generalized muscle weakness  1  5/24 (20.83%) 
Muscle weakness lower limb  1  2/24 (8.33%) 
Muscle weakness upper limb  1  1/24 (4.17%) 
Musculoskeletal and connective tissue disorder - Other, specify: LEG CRAMPS  1  1/24 (4.17%) 
Musculoskeletal and connective tissue disorder - Other, specify: WEAKNESS GENERAL  1  1/24 (4.17%) 
Myalgia  1  13/24 (54.17%) 
Pain in extremity  1  2/24 (8.33%) 
Nervous system disorders   
Akathisia  1  1/24 (4.17%) 
Dizziness  1  6/24 (25.00%) 
Dysgeusia  1  9/24 (37.50%) 
Headache  1  3/24 (12.50%) 
Paresthesia  1  3/24 (12.50%) 
Peripheral sensory neuropathy  1  11/24 (45.83%) 
Psychiatric disorders   
Confusion  1  2/24 (8.33%) 
Depression  1  2/24 (8.33%) 
Hallucinations  1  1/24 (4.17%) 
Insomnia  1  9/24 (37.50%) 
Restlessness  1  1/24 (4.17%) 
Renal and urinary disorders   
Acute kidney injury  1  1/24 (4.17%) 
Urinary retention  1  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1  1/24 (4.17%) 
Bronchopulmonary hemorrhage  1  2/24 (8.33%) 
Cough  1  6/24 (25.00%) 
Dyspnea  1  9/24 (37.50%) 
Hoarseness  1  2/24 (8.33%) 
Laryngeal hemorrhage  1  1/24 (4.17%) 
Pneumonitis  1  1/24 (4.17%) 
Respiratory, thoracic and mediastinal disorders - Other, specify: GURGLING IN CHEST  1  1/24 (4.17%) 
Sore throat  1  2/24 (8.33%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  15/24 (62.50%) 
Dry skin  1  4/24 (16.67%) 
Palmar-plantar erythrodysesthesia syndrome  1  1/24 (4.17%) 
Pruritus  1  6/24 (25.00%) 
Purpura  1  1/24 (4.17%) 
Rash acneiform  1  3/24 (12.50%) 
Rash maculo-papular  1  9/24 (37.50%) 
Skin and subcutaneous tissue disorders - Other, specify: DRY CRACKING FINGER NAILS  1  1/24 (4.17%) 
Skin and subcutaneous tissue disorders - Other, specify: EXCORIATED COCCYX  1  1/24 (4.17%) 
Skin and subcutaneous tissue disorders - Other, specify: FOLLICULITIS RT DEXAMETHASONE  1  1/24 (4.17%) 
Skin and subcutaneous tissue disorders - Other, specify: PEELING HANDS/ARMS/FEET/LEGS  1  1/24 (4.17%) 
Skin hyperpigmentation  1  1/24 (4.17%) 
Skin hypopigmentation  1  1/24 (4.17%) 
Surgical and medical procedures   
Surgical and medical procedures - Other, specify  1  1/24 (4.17%) 
Vascular disorders   
Hot flashes  1  1/24 (4.17%) 
Hypotension  1  4/24 (16.67%) 
Thromboembolic event  1  1/24 (4.17%) 
Vascular disorders - Other, specify: DIAPHORESIS,INTERMITTENT W PAIN  1  1/24 (4.17%) 
Vascular disorders - Other, specify: VASODILATORY SHOCK  1  1/24 (4.17%) 
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Neal Ready, MD
Organization: Duke University Medical Center
Phone: 919 681-6932
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01820754     History of Changes
Other Study ID Numbers: Pro00038093
First Submitted: March 26, 2013
First Posted: March 29, 2013
Results First Submitted: April 23, 2018
Results First Posted: May 22, 2018
Last Update Posted: August 28, 2018