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Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00923845
Recruitment Status : Completed
First Posted : June 18, 2009
Results First Posted : December 21, 2015
Last Update Posted : September 29, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel Fowler, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Renal Cell Carcinoma
Graft-Versus-Host Disease
Engraftment Syndrome
Interventions Drug: Pentostatin
Drug: Sirolimus
Drug: Cyclophosphamide
Procedure: Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
Procedure: Th2 rapa cells
Procedure: Donor Lymphocyte Harvest
Procedure: Induction Therapy
Procedure: GVHD prophylaxis
Procedure: Donor Hematopoietic Stem Cell Harvest
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donors Recipients
Hide Arm/Group Description A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest. Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Period Title: Donor Lymphocyte Harvest
Started 13 0
Completed 13 0
Not Completed 0 0
Period Title: Donor Hematopoietic Stem Cell Harvest
Started 13 0
Completed 13 0
Not Completed 0 0
Period Title: Induction Therapy
Started 0 12
Completed 0 10
Not Completed 0 2
Reason Not Completed
Poor performance status             0             2
Period Title: Allogeneic Stem Cell Therapy
Started 0 10
Received Each of 3 Planned T-Rapa DLI 0 8
Received More Unmanipulated DLI for PD 0 6
Completed 0 10
Not Completed 0 0
Arm/Group Title Donors Recipients Total
Hide Arm/Group Description A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest. Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis. Total of all reporting groups
Overall Number of Baseline Participants 13 12 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
  92.3%
10
  83.3%
22
  88.0%
>=65 years
1
   7.7%
2
  16.7%
3
  12.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 12 participants 25 participants
53.14  (9.06) 58.03  (8.01) 55.48  (8.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Female
7
  53.8%
4
  33.3%
11
  44.0%
Male
6
  46.2%
8
  66.7%
14
  56.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
Hispanic or Latino
0
   0.0%
1
   8.3%
1
   4.0%
Not Hispanic or Latino
11
  84.6%
10
  83.3%
21
  84.0%
Unknown or Not Reported
2
  15.4%
1
   8.3%
3
  12.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 12 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   7.7%
1
   8.3%
2
   8.0%
White
12
  92.3%
11
  91.7%
23
  92.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 12 participants 25 participants
13 12 25
1.Primary Outcome
Title Clinical Regression of Metastatic Renal Cell Carcinoma (Partial Response (PR)) or Complete Remission of Tumor (Complete Response (CR))
Hide Description Response was assessed by computed tomography measurements and the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the largest diameter (LD) of target lesions, taking as reference the baseline sum LD. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest LD recorded since the treatment started or the appearance of one or more new lesions.
Time Frame 6 Months Post-Transplant (Day +100)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 0
Complete Response (CR) 0
Progressive Disease (PD) 8
Stable Disease (SD) 1
Not Applicable (NA) 1
2.Secondary Outcome
Title Count of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 50 months and 6 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donor Recipient
Hide Arm/Group Description:
A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 13 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
12
 100.0%
3.Secondary Outcome
Title Count of Patients Having Neutropenia Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
Hide Description Absolute neutrophil count determination by complete blood count methodology (Absolute Neutrophil Count (ANC) < 500 Cells/µL).
Time Frame During the 21-day PC regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title Count of Patients Having an Infectious Complication Attributable to the Pentostatin and Cyclophosphamide (PC) Regimen
Hide Description Occurrence of infection by Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame During the 21-day PC regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
5.Secondary Outcome
Title Immune Depletion in Cluster of Differentiation 4 (CD4) Cells
Time Frame Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Cells/µL
Baseline
503
(124 to 1487)
Day 21
54
(10 to 107)
6.Secondary Outcome
Title Immune Depletion in Cluster of Differentiation 8 (CD8)+ T Cells
Time Frame Baseline and day 21 (completion of the pentostatin/cyclophosphamide regimen)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: cells/µL
Baseline
239
(56 to 770)
Day 21
45
(12 to 131)
7.Secondary Outcome
Title Immune Suppression
Hide Description Immune suppression is defined by the frequency of elimination of a pre-transplant T cell cytokine value.
Time Frame Cytokine analysis at baseline and within 24 hours of completion of the pentostatin/cyclophosphamide regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: % of undetectable cytokine measurements
Positive at baseline 100
Negative at baseline 0
Positive 24 hours after regimen 0
Negative 24 hours after regimen 100
8.Secondary Outcome
Title Engraftment Donor T Cell and Myeloid Cell Chimerism
Hide Description Donor Genetic Elements by variable number tandem repeat-polymerase chain reaction (VNTR-PCR) Analysis.
Time Frame Days 14, 28, 45, and 60 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Percent Donor by VNTR-PCR Analysis
Day 14 donor T cell chimerism
61
(7 to 77)
Day 28 donor T cell chimerism
72
(9 to 91)
Day 45 donor T cell chimerism
74
(21 to 88)
Day 60 donor T cell chimerism
77
(26 to 95)
Day 14 myeloid cell chimerism
0
(0 to 27)
Day 28 myeloid cell chimerism
13
(4 to 50)
Day 45 myeloid cell chimerism
18
(11 to 67)
Day 60 myeloid cell chimerism
26
(13 to 76)
9.Secondary Outcome
Title Count of Patients With Grade II or Greater Acute Graft Versus Host Disease (GVHD) in First 100 Days Post-Transplant
Hide Description Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).
Time Frame 100 days post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
10.Secondary Outcome
Title Count of Patients With Late Acute Graft Versus Host Disease (GVHD) After Day 100 Post-Transplant
Hide Description Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD is assessed by the 1994 Consensus Conference on Acute GVHD grading criteria. Acute GVHD may include rash, diarrhea, and liver damage (i.e. rash Grading: <25% body surface area (BSA) = 1, rash 25-50% BSA = 2, generalized erythroderma = 3, and desquamation and bullae = 4); liver Grading: total bilirubin 2-3 mg/dl = 1, total bilirubin 3-6 mg/dl =2, total bilirubin 6-15 mg/dl =3, and total bilirubin >15 mg/dl = 4)).
Time Frame 100 days post-transplant through 5 years post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Only 6 patients were evaluable for this endpoint due to death due to malignancy.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
11.Secondary Outcome
Title Count of Patients With Chronic Graft Versus Host Disease (GVHD)
Hide Description Chronic GVHD was assessed by the 2005 Chronic GVHD Consensus Project. Chronic GVHS may include dryness of the mouth and eyes, weight loss, liver damage and lung damage leading to cough and shortness of breath (i.e. skin Grading: no symptoms = 0, <18% body surface area (BSA) = 1, 19-50% BSA = 2, and >50% BSA = 3); oral cavity Grading: no symptoms = 0, mild symptoms = 1, moderate symptoms =2 and severe symptoms =3)).
Time Frame For the duration of post-transplant follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Only 4 patients were evaluable due to mortality from malignancy.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
12.Secondary Outcome
Title Cluster of Differentiation 4 (CD4) T Cells Immune Reconstitution
Hide Description CD4 T Cells immune reconstitution is defined as distribution of CD4+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.
Time Frame Days 14, 60, and 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The values for each subset were stable at days 60 and 100 relative to day 14 values.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Standard Deviation)
Unit of Measure: Percentage of total CD4 cell subsets
Day 14 22  (3)
Day 60 20  (2)
Day 100 19  (2)
13.Secondary Outcome
Title Cluster of Differentiation 8 (CD8)+ T Cells Immune Reconstitution
Hide Description CD8+ T Cells immune reconstitution is defined as distribution of CD8+ T cells subsets within naïve, central memory, effector memory, and effector memory-RA cells analyzed by flow cytometry.
Time Frame Days 14, 60, and 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The values for each subset were stable at days 60 and 100 relative to day 14 values.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Standard Deviation)
Unit of Measure: Percent of total CD8 cell subsets
Day 14 6  (1)
Day 60 5  (1)
Day 100 4  (1)
14.Secondary Outcome
Title Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th2 Transcription Factor GATA Binding Protein 3 (GATA-3)
Hide Description Intra-cellular flow cytometry detection of GATA3 transcription factor.
Time Frame Days 14, 60 and 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The values for each subset were stable at days 60 and 100 relative to day 14 values.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Percentage of total CD4+ T cells
Day 14
42
(31 to 64)
Day 60
37
(28 to 44)
Day 100
43
(20 to 49)
15.Secondary Outcome
Title Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the Th1 Transcription Factor T-bet
Hide Description CD4+ T cells were analyzed by flow cytometry for intracellular detection of Tbet transcription factor.
Time Frame Days 14, 60, and 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The values for each subset were stable at days 60 and 100 relative to day 14 values.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Percentage of total CD4+T cells
Day 14
8
(3 to 16)
Day 60
8
(1 to 17)
Day 100
6
(2 to 19)
16.Secondary Outcome
Title Percentage of Cluster of Differentiation 4 (CD4)+ T Cells Expressing the T-reg Transcription Factor Forkhead Box P3 (FoxP3))
Hide Description CD4+ T cells were analyzed by flow cytometry for intracellular expression of FoxP3.
Time Frame Days 14, 60, and 100 post transplant
Hide Outcome Measure Data
Hide Analysis Population Description
The values for each subset were stable at days 60 and 100 relative to day 14 values.
Arm/Group Title Recipient
Hide Arm/Group Description:
Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Percentage of total CD4+ T cells
Day 14
8
(4 to 14)
Day 60
6
(1 to 13)
Day 100
3
(1 to 10)
Time Frame 50 months and 6 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donor Recipient
Hide Arm/Group Description A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest. Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
All-Cause Mortality
Donor Recipient
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)      7/12 (58.33%)    
Show Serious Adverse Events Hide Serious Adverse Events
Donor Recipient
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      8/12 (66.67%)    
Blood and lymphatic system disorders     
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Gastrointestinal disorders     
Dysphagia (difficulty swallowing)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Hemorrhage, GI::Lower GI NOS  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Nausea  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Vomiting  1  0/13 (0.00%)  0 1/12 (8.33%)  1
General disorders     
Death not associated with CTCAE term::Death NOS  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Death not associated with CTCAE term::Disease progression NOS  1  0/13 (0.00%)  0 5/12 (41.67%)  5
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders     
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Pleural effusion (non-malignant)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  0/13 (0.00%)  0 1/12 (8.33%)  1
1
Term from vocabulary, CTC v2.0
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%
Donor Recipient
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      12/12 (100.00%)    
Blood and lymphatic system disorders     
Hemoglobin  1  0/13 (0.00%)  0 9/12 (75.00%)  61
Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis)  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Hemorrhage/Bleeding - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils::Blood  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Infection with unknown ANC::Blood  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Leukocytes (total WBC)  1  0/13 (0.00%)  0 8/12 (66.67%)  43
Neutrophils/granulocytes (ANC/AGC)  1  0/13 (0.00%)  0 6/12 (50.00%)  25
PTT (Partial Thromboplastin Time)  1  0/13 (0.00%)  0 1/12 (8.33%)  3
Platelets  1  0/13 (0.00%)  0 5/12 (41.67%)  60
Cardiac disorders     
Cardiac Arrhythmia - Other  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Cardiac General - Other  1  0/13 (0.00%)  0 2/12 (16.67%)  4
Edema: limb  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Hypertension  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Hypotension  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Syncope (fainting)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Thrombosis/embolism (vascular access-related)  1  0/13 (0.00%)  0 4/12 (33.33%)  5
Endocrine disorders     
Thyroid function, low (hypothyroidism)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Eye disorders     
Dry eye syndrome  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Ocular/Visual - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal disorders     
Anorexia  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Constipation  1  0/13 (0.00%)  0 3/12 (25.00%)  4
Diarrhea  1  0/13 (0.00%)  0 3/12 (25.00%)  3
Dry mouth/salivary gland (xerostomia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Gastritis (including bile reflux gastritis)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Gastrointestinal - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Heartburn/dyspepsia  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Hemorrhage, GI::Cecum/appendix  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Hemorrhage, GI::Liver  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Hemorrhage, GI::Rectum  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infection with unknown ANC::Small bowel NOS  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Mucositis/stomatitis (clinical exam)::Oral cavity  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Mucositis/stomatitis (functional/symptomatic)::Oral cavity  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Nausea  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Pain::Oral cavity  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Vomiting  1  0/13 (0.00%)  0 1/12 (8.33%)  12
General disorders     
Fatigue (asthenia, lethargy, malaise)  1  0/13 (0.00%)  0 5/12 (41.67%)  5
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Growth and Development - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain - Other  1  0/13 (0.00%)  0 5/12 (41.67%)  5
Pain::Pain NOS  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Syndromes - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Weight loss  1  0/13 (0.00%)  0 2/12 (16.67%)  4
Hepatobiliary disorders     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  0/13 (0.00%)  0 5/12 (41.67%)  18
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  0/13 (0.00%)  0 6/12 (50.00%)  44
Albumin, serum-low (hypoalbuminemia)  1  0/13 (0.00%)  0 5/12 (41.67%)  15
Alkaline phosphatase  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Hepatobiliary/Pancreas - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations     
Infection - Other  1  0/13 (0.00%)  0 2/12 (16.67%)  4
Infection with normal ANC or Grade 1 or 2 neutrophils::Catheter-related  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory)  1  0/13 (0.00%)  0 3/12 (25.00%)  3
Adrenal insufficiency  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Alkalosis (metabolic or respiratory)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Amylase  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Bilirubin (hyperbilirubinemia)  1  0/13 (0.00%)  0 3/12 (25.00%)  4
Calcium, serum-high (hypercalcemia)  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Glucose, serum-high (hyperglycemia)  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Lipase  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Magnesium, serum-high (hypermagnesemia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Metabolic/Laboratory - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Phosphate, serum-low (hypophosphatemia)  1  0/13 (0.00%)  0 8/12 (66.67%)  25
Potassium, serum-high (hyperkalemia)  1  0/13 (0.00%)  0 3/12 (25.00%)  3
Potassium, serum-low (hypokalemia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Sodium, serum-low (hyponatremia)  1  0/13 (0.00%)  0 7/12 (58.33%)  34
Musculoskeletal and connective tissue disorders     
Pain::Back  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Pain::Bone  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Pain::Buttock  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain::Chest wall  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain::Chest/thorax NOS  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain::Extremity-limb  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain::Joint  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Nervous system disorders     
Confusion  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Mood alteration::Anxiety  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Mood alteration::Depression  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Neurology - Other  1  0/13 (0.00%)  0 4/12 (33.33%)  4
Neuropathy: sensory  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pain::Head/headache  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Speech impairment (e.g., dysphasia or aphasia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Renal and urinary disorders     
Creatinine  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Cystitis  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Hemorrhage, GU::Urinary NOS  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Infection with normal ANC or Grade 1 or 2 neutrophils::Urinary tract NOS  1  0/13 (0.00%)  0 2/12 (16.67%)  3
Renal failure  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Renal/Genitourinary - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Reproductive system and breast disorders     
Pain::Pelvis  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Vaginal discharge (non-infectious)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Dyspnea (shortness of breath)  1  0/13 (0.00%)  0 3/12 (25.00%)  3
Hypoxia  1  0/13 (0.00%)  0 4/12 (33.33%)  6
Infection  1 [1]  0/13 (0.00%)  0 1/12 (8.33%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils::Lung (pneumonia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Upper airway NOS  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Infection with unknown ANC::Lung (pneumonia)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infection with unknown ANC::Trachea  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Nasal cavity/paranasal sinus reactions  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Pleural effusion (non-malignant)  1  0/13 (0.00%)  0 4/12 (33.33%)  4
Pneumothorax  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Pulmonary/Upper Respiratory - Other  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)  1  0/13 (0.00%)  0 1/12 (8.33%)  2
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  0/13 (0.00%)  0 3/12 (25.00%)  3
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils  1 [2]  0/13 (0.00%)  0 1/12 (8.33%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Skin (cellulitis)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils::Ungual (nails)  1  0/13 (0.00%)  0 1/12 (8.33%)  1
Rash/desquamation  1  0/13 (0.00%)  0 3/12 (25.00%)  4
Rash: acne/acneiform  1  0/13 (0.00%)  0 2/12 (16.67%)  2
Ulceration  1  0/13 (0.00%)  0 2/12 (16.67%)  5
1
Term from vocabulary, CTC v2.0
Indicates events were collected by systematic assessment
[1]
(documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)::Lung (pneumonia)
[2]
(ANC <1.0 x 10e9/L)::Skin (cellulites)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Daniel Fowler
Organization: National Cancer Institute
Phone: 301-435-8641
EMail: fowlerda@mail.nih.gov
Layout table for additonal information
Responsible Party: Daniel Fowler, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00923845     History of Changes
Obsolete Identifiers: NCT00641485
Other Study ID Numbers: 080088
08-C-0088
First Submitted: June 17, 2009
First Posted: June 18, 2009
Results First Submitted: November 16, 2015
Results First Posted: December 21, 2015
Last Update Posted: September 29, 2017