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Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients Undergoing a Donor Stem Cell Transplant For Hematological Cancer

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ClinicalTrials.gov Identifier: NCT00589563
Recruitment Status : Completed
First Posted : January 9, 2008
Results First Posted : August 12, 2014
Last Update Posted : September 10, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Infection
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Secondary Myelofibrosis
Small Intestine Cancer
Interventions Biological: anti-thymocyte globulin
Drug: cyclophosphamide
Drug: etoposide
Drug: fludarabine phosphate
Drug: melphalan
Drug: methotrexate
Drug: sirolimus
Drug: tacrolimus
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
Radiation: total-body irradiation
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Period Title: Overall Study
Started 32
Completed 32
Not Completed 0
Arm/Group Title All Patients
Hide Arm/Group Description All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
59.5
(19 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
19
  59.4%
Male
13
  40.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Acute Myeloid Leukemia 14
Myelodysplastic Syndrome 6
Acute Lymphoblastic Leukemia 3
Chronic Myeloid Leukemia 3
Non-Hodgkin Lymphoma 3
Myeloproliferative Disorder 2
Chronic Lymphocytic Leukemia 1
[1]
Measure Description: Diagnosis at time of transplant.
Disease Status (American Society for Blood and Marrow Transplantation Guidelines)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Standard Risk 14
High/Intermediate Risk 18
[1]
Measure Description: Disease status at time of transplant.
Patient/Donor Cytomegalovirus (CMV) infection status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Positive/Negative 12
Positive/Positive 12
Negative/Negative 3
Negative/Positive 5
[1]
Measure Description: Patient CMV status listed first followed by Donor CMV status. Both are determined at time of transplant.
Human Leukocyte Antigen (HLA) Match Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
10/10 Matched 18
1 Mismatch 12
2 Mismatches 1
3 Mismatches 1
[1]
Measure Description: All mismatches occur at A, B, C, or DR.
Conditioning Regimen  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Fludarabine/Melphalan 23
Fractionated Total Body Irradiation/Cytoxan 4
Fractionated Total Body Irradiation/Etoposide 5
Patient/donor sex match  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 32 participants
Male patient/Female donor 3
Others 29
1.Primary Outcome
Title Cumulative Incidence of Grade II-IV Acute Graft-Versus-Host Disease (GVHD) at Day 100
Hide Description Patients were evaluated for the development of acute GVHD within the first 100 days post HSCT. The cumulative incidence of grade II-IV acute GVHD was determined using competing risk analysis. Competing risks for acute GVHD were death and nonengraftment.
Time Frame 100 Days Post Hematopoietic Stem Cell Transplant (HSCT)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients developing aGVHD
37.3
(22.4 to 62.0)
2.Primary Outcome
Title Severity of Acute GVHD
Hide Description All patients were considered for the evaluation of the severity of acute GVHD.
Time Frame 100 Days Post HSCT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
No Acute GVHD 9
Yes - Grade I 9
Yes- Grade II 9
Yes- Grade III 1
Yes - Grade IV 0
No- Inevaluable (graft failures) 4
3.Primary Outcome
Title Cumulative Incidence of Chronic GVHD
Hide Description Patients were evaluated for the development of chronic GVHD from 101 days post HSCT to last contact or documented evidence of the disease. The cumulative incidence of chronic GVHD was determined using competing risk analysis. Competing risks for GVHD were death and nonengraftment.
Time Frame 2 year point estimate was provided.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients developing cGVHD
62.5
(47.8 to 81.7)
4.Primary Outcome
Title Severity of Chronic GVHD
Hide Description All Patients were considered for the evaluation of chronic GVHD severity.
Time Frame Patients were evaluated until they developed chronic GVHD, a median of 130 days post HSCT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
No Chronic GVHD 4
Yes- Limited 4
Yes - Extensive 17
No- Inevaluable (graft failure/died <day 100) 7
5.Secondary Outcome
Title Time to Absolute Neutrophil Count Recovery (Engraftment)
Hide Description Absolute neutrophil count (ANC) recovery is defined as an ANC of ≥ 0.5 x 10^9/L (500/mm3) for three consecutive laboratory values obtained on different days
Time Frame Patients were evaluated until neutrophil recovery, a median of 15 days post HSCT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
28 of the 32 patients had absolute neutrophil count recovery.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 28
Median (Full Range)
Unit of Measure: Days
14.5
(10 to 26)
6.Secondary Outcome
Title Time to Platelet Count Recovery (Engraftment)
Hide Description Platelet recovery is defined as the first date of three consecutive laboratory values ≥ 25 x 10^9 L obtained on different days.
Time Frame Patients were evaluated until platelet recovery, a median of 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
27 of the 32 patients had platelet recovery.
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 27
Median (Full Range)
Unit of Measure: Days
14
(10 to 40)
7.Secondary Outcome
Title Occurence of Infections Including Cytomegalovirus and Epstein-Barr Virus Reactivation
Hide Description Participants were monitored throughout the trial (median of 28 months) for various infections/complications.
Time Frame Median Follow Up: 28 months (Range: 1-49 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
Neither CMV or EBV 16
CMV reactivation only 9
EBV only 3
Both CMV and EBV 4
8.Secondary Outcome
Title Occurrence of Thrombotic Microangiopathy
Hide Description Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed TMA.
Time Frame Median Follow Up: 28 Months (Range: 1-49 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
7
9.Secondary Outcome
Title Occurence of Sinusoidal Obstructive Syndrome (SOS)
Hide Description Participants were monitored throughout the trial (median of 28 months) for various infections/complications. This is the number of participants who developed SOS.
Time Frame Median Follow Up: 28 Months (Range: 1-49 Months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
1
10.Secondary Outcome
Title Non-relapse Mortality at 100 Days Post HSCT
Hide Description Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
Time Frame 100 day point estimate was provided
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients with a NRM
9.4
(3.2 to 27.5)
11.Secondary Outcome
Title Non-relapse Mortality at Two Years Post HSCT
Hide Description Patients were evaluated for non-relapse mortality (NRM) throughout the study. Non-relapse mortality was considered any death not attributable to relapse or disease progression. The cumulative incidence of NRM was determined using competing risk analysis. Competing risks for NRM were death due to disease progression, relapse and nonengraftment.
Time Frame 2 year point estimate was provided.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients with a NRM
15.6
(7.0 to 35.0)
12.Secondary Outcome
Title Overall Survival at Two Years Post HSCT
Hide Description Patients were evaluated for survival (OS) throughout the study. Kaplan Meier estiamtes were calculated for overall survival using time from HSCT to death of any cause or for surviving patients last contact date.
Time Frame 2 year point estimate was provided.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients who died
65.6
(53.7 to 75.2)
13.Secondary Outcome
Title Event Free Survival at Two Years Post HSCT
Hide Description Patients were evaluated for event free survival (EFS) throughout the study. Events were defined as death, relapse, progression, or nonengraftment. Kaplan Meier estimates were calculated as time from HSCT to event.
Time Frame 2 year point estimate was provided.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients with an event
61.3
(49.9 to 70.8)
14.Secondary Outcome
Title Incidence of Disease Relapse/Progression at 2 Years Post HSCT
Hide Description Patients were evaluated for relapse/progression post transplant throughout the study. The cumulative incidence of relapse/progression was determined using competing risk analysis. Competing risks for relapse were non-relapse mortality and nonengraftment.
Time Frame 2 year point estimate was provided.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of patients who relapsed
12.5
(5.0 to 31.3)
Time Frame 180 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   9/31 (29.03%)    
Blood and lymphatic system disorders   
Blood disorder * 1  1/31 (3.23%)  1
Cardiac disorders   
Atrial flutter * 1  1/31 (3.23%)  1
Myocardial ischemia * 1  1/31 (3.23%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/31 (6.45%)  2
General disorders   
Ill-defined disorder * 1  1/31 (3.23%)  1
Multi-organ failure * 1  2/31 (6.45%)  2
Pain * 1  1/31 (3.23%)  1
Hepatobiliary disorders   
Portal hypertension * 1  1/31 (3.23%)  1
Infections and infestations   
Abdominal infection * 1  1/31 (3.23%)  1
Catheter related infection * 1  1/31 (3.23%)  1
Colitis, infectious (e.g., Clostridium difficile) * 1  1/31 (3.23%)  1
Infection * 1  1/31 (3.23%)  1
Opportunistic infection * 1  2/31 (6.45%)  2
Pneumonia * 1  1/31 (3.23%)  1
Sepsis * 1  2/31 (6.45%)  2
Musculoskeletal and connective tissue disorders   
Muscle weakness * 1  1/31 (3.23%)  1
Renal and urinary disorders   
Renal failure * 1  2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome * 1  1/31 (3.23%)  1
Pulmonary hemorrhage * 1  1/31 (3.23%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%) # Events
Total   31/31 (100.00%)    
Blood and lymphatic system disorders   
Blood disorder * 1  2/31 (6.45%)  2
Febrile neutropenia * 1  16/31 (51.61%)  16
Hemoglobin decreased * 1  31/31 (100.00%)  31
Hemolysis * 1  2/31 (6.45%)  2
Lymph node pain * 1  1/31 (3.23%)  1
Lymphatic disorder * 1  3/31 (9.68%)  3
Thrombotic microangiopathy * 1  6/31 (19.35%)  6
Cardiac disorders   
Atrial fibrillation * 1  1/31 (3.23%)  1
Atrial flutter * 1  1/31 (3.23%)  1
Cardiac disorder * 1  1/31 (3.23%)  1
Left ventricular dysfunction * 1  2/31 (6.45%)  2
Left ventricular failure * 1  1/31 (3.23%)  1
Pericardial effusion * 1  3/31 (9.68%)  3
Pericarditis * 1  1/31 (3.23%)  1
Restrictive cardiomyopathy * 1  1/31 (3.23%)  1
Sinus bradycardia * 1  2/31 (6.45%)  2
Sinus tachycardia * 1  23/31 (74.19%)  23
Supraventricular tachycardia * 1  1/31 (3.23%)  1
Ventricular tachycardia * 1  1/31 (3.23%)  1
Ear and labyrinth disorders   
Ear disorder * 1  1/31 (3.23%)  1
External ear inflammation * 1  1/31 (3.23%)  1
Middle ear inflammation * 1  1/31 (3.23%)  1
Endocrine disorders   
Cushingoid * 1  3/31 (9.68%)  3
Hyperthyroidism * 1  1/31 (3.23%)  1
Eye disorders   
Dry eye syndrome * 1  3/31 (9.68%)  3
Eye disorder * 1  4/31 (12.90%)  4
Eye pain * 1  1/31 (3.23%)  1
Photophobia * 1  1/31 (3.23%)  1
Vision blurred * 1  3/31 (9.68%)  3
Watering eyes * 1  1/31 (3.23%)  1
Gastrointestinal disorders   
Abdominal distension * 1  19/31 (61.29%)  19
Abdominal pain * 1  23/31 (74.19%)  23
Anal pain * 1  3/31 (9.68%)  3
Ascites * 1  1/31 (3.23%)  1
Colonic hemorrhage * 1  1/31 (3.23%)  1
Constipation * 1  9/31 (29.03%)  9
Diarrhea * 1  29/31 (93.55%)  29
Diarrhea associated with GVHD for BMT studies, if specified in the protocol. * 1  1/31 (3.23%)  1
Dry mouth * 1  7/31 (22.58%)  7
Dyspepsia * 1  12/31 (38.71%)  12
Dysphagia * 1  5/31 (16.13%)  5
Ear, nose and throat examination abnormal * 1  22/31 (70.97%)  22
Esophageal pain * 1  1/31 (3.23%)  1
Esophagitis * 1  2/31 (6.45%)  2
Fecal incontinence * 1  4/31 (12.90%)  4
Flatulence * 1  4/31 (12.90%)  4
Gastritis * 1  3/31 (9.68%)  3
Gastrointestinal disorder * 1  2/31 (6.45%)  2
Gingival pain * 1  1/31 (3.23%)  1
Hemorrhoids * 1  4/31 (12.90%)  4
Mucositis oral * 1  18/31 (58.06%)  18
Nausea * 1  29/31 (93.55%)  29
Oral hemorrhage * 1  1/31 (3.23%)  1
Oral pain * 1  3/31 (9.68%)  3
Proctitis * 1  1/31 (3.23%)  1
Rectal hemorrhage * 1  2/31 (6.45%)  2
Rectal pain * 1  3/31 (9.68%)  3
Upper gastrointestinal hemorrhage * 1  1/31 (3.23%)  1
Vomiting * 1  25/31 (80.65%)  25
General disorders   
Chest pain * 1  3/31 (9.68%)  3
Chills * 1  25/31 (80.65%)  25
Edema * 1  1/31 (3.23%)  1
Edema limbs * 1  25/31 (80.65%)  25
Facial pain * 1  4/31 (12.90%)  4
Fatigue * 1  30/31 (96.77%)  30
Fever * 1  19/31 (61.29%)  19
Flu-like symptoms * 1  1/31 (3.23%)  1
Gait abnormal * 1  2/31 (6.45%)  2
General symptom * 1  3/31 (9.68%)  3
Ill-defined disorder * 1  4/31 (12.90%)  4
Injection site reaction * 1  11/31 (35.48%)  11
Irritability * 1  1/31 (3.23%)  1
Localized edema * 1  8/31 (25.81%)  8
Pain * 1  17/31 (54.84%)  17
Immune system disorders   
Cytokine release syndrome * 1  1/31 (3.23%)  1
Hypersensitivity * 1  3/31 (9.68%)  3
Infections and infestations   
Bladder infection * 1  3/31 (9.68%)  3
Bronchitis * 1  1/31 (3.23%)  1
Catheter related infection * 1  1/31 (3.23%)  1
Colitis, infectious (e.g., Clostridium difficile) * 1  4/31 (12.90%)  4
Conjunctivitis infective * 1  1/31 (3.23%)  1
Infection * 1  8/31 (25.81%)  8
Infectious colitis * 1  2/31 (6.45%)  2
Lip infection * 1  1/31 (3.23%)  1
Opportunistic infection * 1  11/31 (35.48%)  11
Pancreas infection * 1  2/31 (6.45%)  2
Paranasal sinus infection * 1  1/31 (3.23%)  1
Pneumonia * 1  6/31 (19.35%)  6
Sepsis * 1  15/31 (48.39%)  15
Sinusitis * 1  1/31 (3.23%)  1
Skin infection * 1  1/31 (3.23%)  1
Tracheitis * 1  1/31 (3.23%)  1
Upper respiratory infection * 1  4/31 (12.90%)  4
Urinary tract infection * 1  3/31 (9.68%)  3
Injury, poisoning and procedural complications   
Bruising * 1  14/31 (45.16%)  14
Dermatitis radiation * 1  2/31 (6.45%)  2
Intraoperative venous injury - Vein-portal vein * 1  1/31 (3.23%)  1
Postoperative hemorrhage * 1  1/31 (3.23%)  1
Radiation recall reaction (dermatologic) * 1  2/31 (6.45%)  2
Vascular access complication * 1  1/31 (3.23%)  1
Wound dehiscence * 1  2/31 (6.45%)  2
Investigations   
Activated partial thromboplastin time prolonged * 1  1/31 (3.23%)  1
Alanine aminotransferase increased * 1  29/31 (93.55%)  29
Alkaline phosphatase increased * 1  23/31 (74.19%)  23
Amylase increased * 1  2/31 (6.45%)  2
Aspartate aminotransferase increased * 1  30/31 (96.77%)  30
Bilirubin increased * 1  7/31 (22.58%)  7
Creatine phosphokinase increased * 1  1/31 (3.23%)  1
Creatinine increased * 1  21/31 (67.74%)  21
Gamma-glutamyltransferase increased * 1  1/31 (3.23%)  1
Laboratory test abnormal * 1  4/31 (12.90%)  4
Leukocyte count decreased * 1  31/31 (100.00%)  31
Lipase increased * 1  2/31 (6.45%)  2
Lymphocyte count decreased * 1  26/31 (83.87%)  26
Neutrophil count decreased * 1  31/31 (100.00%)  31
Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. * 1  1/31 (3.23%)  1
Platelet count decreased * 1  31/31 (100.00%)  31
Serum cholesterol increased * 1  20/31 (64.52%)  20
Weight gain * 1  11/31 (35.48%)  11
Weight loss * 1  17/31 (54.84%)  17
Metabolism and nutrition disorders   
Acidosis * 1  4/31 (12.90%)  4
Alkalosis * 1  5/31 (16.13%)  5
Anorexia * 1  26/31 (83.87%)  26
Blood bicarbonate decreased * 1  20/31 (64.52%)  20
Blood glucose increased * 1  31/31 (100.00%)  31
Blood uric acid increased * 1  1/31 (3.23%)  1
Dehydration * 1  2/31 (6.45%)  2
Iron overload * 1  1/31 (3.23%)  1
Serum albumin decreased * 1  30/31 (96.77%)  30
Serum calcium decreased * 1  31/31 (100.00%)  31
Serum calcium increased * 1  7/31 (22.58%)  7
Serum glucose decreased * 1  3/31 (9.68%)  3
Serum magnesium decreased * 1  31/31 (100.00%)  31
Serum magnesium increased * 1  6/31 (19.35%)  6
Serum phosphate decreased * 1  28/31 (90.32%)  28
Serum potassium decreased * 1  29/31 (93.55%)  29
Serum potassium increased * 1  6/31 (19.35%)  6
Serum sodium decreased * 1  31/31 (100.00%)  31
Serum sodium increased * 1  1/31 (3.23%)  1
Serum triglycerides increased * 1  28/31 (90.32%)  28
Musculoskeletal and connective tissue disorders   
Back pain * 1  16/31 (51.61%)  16
Bone pain * 1  7/31 (22.58%)  7
Buttock pain * 1  2/31 (6.45%)  2
Joint pain * 1  11/31 (35.48%)  11
Muscle weakness * 1  20/31 (64.52%)  20
Muscle weakness lower limb * 1  6/31 (19.35%)  6
Muscle weakness upper limb * 1  1/31 (3.23%)  1
Musculoskeletal disorder * 1  3/31 (9.68%)  3
Myalgia * 1  5/31 (16.13%)  5
Myositis * 1  1/31 (3.23%)  1
Neck pain * 1  9/31 (29.03%)  9
Osteoporosis * 1  1/31 (3.23%)  1
Pain in extremity * 1  19/31 (61.29%)  19
Nervous system disorders   
Depressed level of consciousness * 1  5/31 (16.13%)  5
Dizziness * 1  16/31 (51.61%)  16
Encephalopathy * 1  1/31 (3.23%)  1
Headache * 1  27/31 (87.10%)  27
Memory impairment * 1  4/31 (12.90%)  4
Neuralgia * 1  2/31 (6.45%)  2
Neurological disorder NOS * 1  2/31 (6.45%)  2
Nystagmus * 1  1/31 (3.23%)  1
Peripheral motor neuropathy * 1  3/31 (9.68%)  3
Peripheral sensory neuropathy * 1  10/31 (32.26%)  10
Sinus pain * 1  2/31 (6.45%)  2
Taste alteration * 1  6/31 (19.35%)  6
Tremor * 1  9/31 (29.03%)  9
Psychiatric disorders   
Agitation * 1  7/31 (22.58%)  7
Anxiety * 1  25/31 (80.65%)  25
Confusion * 1  6/31 (19.35%)  6
Depression * 1  12/31 (38.71%)  12
Insomnia * 1  24/31 (77.42%)  24
Psychosis * 1  1/31 (3.23%)  1
Renal and urinary disorders   
Bladder obstruction * 1  1/31 (3.23%)  1
Bladder pain * 1  3/31 (9.68%)  3
Bladder spasm * 1  3/31 (9.68%)  3
Bladder stenosis * 1  1/31 (3.23%)  1
Cystitis * 1  1/31 (3.23%)  1
Hemorrhage urinary tract * 1  7/31 (22.58%)  7
Protein urine positive * 1  11/31 (35.48%)  11
Renal failure * 1  1/31 (3.23%)  1
Urethral pain * 1  5/31 (16.13%)  5
Urinary frequency * 1  7/31 (22.58%)  7
Urinary incontinence * 1  3/31 (9.68%)  3
Urinary retention * 1  6/31 (19.35%)  6
Urogenital disorder * 1  4/31 (12.90%)  4
Reproductive system and breast disorders   
Pelvic pain * 1  1/31 (3.23%)  1
Perineal pain * 1  2/31 (6.45%)  2
Scrotal pain * 1  1/31 (3.23%)  1
Vaginal discharge * 1  1/31 (3.23%)  1
Vaginal dryness * 1  1/31 (3.23%)  1
Vaginal hemorrhage * 1  2/31 (6.45%)  2
Vaginal pain * 1  2/31 (6.45%)  2
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome * 1  2/31 (6.45%)  2
Allergic rhinitis * 1  4/31 (12.90%)  4
Atelectasis * 1  8/31 (25.81%)  8
Bronchopulmonary hemorrhage * 1  4/31 (12.90%)  4
Bronchospasm * 1  2/31 (6.45%)  2
Cough * 1  23/31 (74.19%)  23
Dyspnea * 1  19/31 (61.29%)  19
Hemorrhage nasal * 1  11/31 (35.48%)  11
Hiccough * 1  4/31 (12.90%)  4
Hypoxia * 1  8/31 (25.81%)  8
Nasal congestion * 1  8/31 (25.81%)  8
Pharyngeal examination abnormal * 1  1/31 (3.23%)  1
Pharyngeal mucositis * 1  1/31 (3.23%)  1
Pharyngolaryngeal pain * 1  2/31 (6.45%)  2
Pleural effusion * 1  12/31 (38.71%)  12
Pneumonitis * 1  11/31 (35.48%)  11
Respiratory disorder * 1  5/31 (16.13%)  5
Voice alteration * 1  3/31 (9.68%)  3
Skin and subcutaneous tissue disorders   
Alopecia * 1  18/31 (58.06%)  18
Decubitus ulcer * 1  4/31 (12.90%)  4
Dry skin * 1  15/31 (48.39%)  15
Hand-and-foot syndrome * 1  1/31 (3.23%)  1
Petechiae * 1  12/31 (38.71%)  12
Pruritus * 1  19/31 (61.29%)  19
Rash desquamating * 1  28/31 (90.32%)  28
Skin disorder * 1  10/31 (32.26%)  10
Skin hyperpigmentation * 1  11/31 (35.48%)  11
Skin ulceration * 1  1/31 (3.23%)  1
Sweating * 1  2/31 (6.45%)  2
Urticaria * 1  1/31 (3.23%)  1
Vascular disorders   
Flushing * 1  14/31 (45.16%)  14
Hematoma * 1  6/31 (19.35%)  6
Hemorrhage * 1  4/31 (12.90%)  4
Hypertension * 1  20/31 (64.52%)  20
Hypotension * 1  17/31 (54.84%)  17
Peripheral ischemia * 1  1/31 (3.23%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, meddra10.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ryotaro Nakamura
Organization: City of Hope Medical Center
Phone: 626-256-4673 ext 65285
Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT00589563     History of Changes
Other Study ID Numbers: 06141
P30CA033572 ( U.S. NIH Grant/Contract )
CHNMC-06141
CDR0000579340 ( Registry Identifier: NCI PDQ )
First Submitted: December 21, 2007
First Posted: January 9, 2008
Results First Submitted: July 21, 2014
Results First Posted: August 12, 2014
Last Update Posted: September 10, 2014