Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 315 for:    BENDAMUSTINE

Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01234467
Recruitment Status : Completed
First Posted : November 4, 2010
Results First Posted : April 26, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diffuse Large B-Cell Lymphoma
Lymphoma, Diffuse Large-Cell
Diffuse Large-Cell Lymphoma
Lymphoma
Interventions Drug: Bendamustine
Drug: Rituximab
Enrollment 23
Recruitment Details 23 patients were enrolled between March 2011 and May 2013.
Pre-assignment Details 28 patients were assessed for eligibility; 4 patients were excluded for not meeting the inclusion criteria and 1 patient eventually declined to participate. Leaving 23 patients enrolled.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Period Title: Overall Study
Started 23
Completed 11
Not Completed 12
Reason Not Completed
Adverse Event             3
Death             2
Withdrawal by Subject             2
Disease Progression             2
Clinical deterioration             1
Physician Decision             1
Other complicating disease (stroke)             1
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
80
(65 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
11
  47.8%
Male
12
  52.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 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
2
   8.7%
White
21
  91.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
II
4
  17.4%
III
7
  30.4%
IV
12
  52.2%
[1]
Measure Description: stage I: 1 group of lymph nodes affected stage II: 2 or more groups of lymph nodes affected either above or below the diaphragm (muscle that separates the chest from the abdomen) stage III: lymph nodes affected on both sides of the diaphragm stage IV: lymphoma is found in organs outside the lymphatic system or in the bone marrow.
ECOG Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
0
2
   8.7%
1
9
  39.1%
2
6
  26.1%
3
6
  26.1%
[1]
Measure Description: The ECOG Performance Status was developed by the Eastern Cooperative Oncology Group. It describes a patient’s level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). 0 being fully active, able to carry on all pre-disease performance without restriction and 5 being dead.
International Prognostic Index (IPI)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
2
5
  21.7%
3
5
  21.7%
4
8
  34.8%
5
5
  21.7%
[1]
Measure Description: International Prognosis Index is a clinical tool developed by oncologists to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma. 0 points represent low-risk and higher numbers represent higher risk.
Lactate Dehydrogenase (LDH)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Normal
8
  34.8%
Elevated
15
  65.2%
[1]
Measure Description: Lactate dehydrogenase (LDH) is an enzyme that helps the process of turning sugar into energy for your cells to use. It is often elevated in patients with lymphoma, but normal levels are associated with better response to therapy and longer survival.
Pathology Subtype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Non-Germinal Center
12
  52.2%
Germinal Center
7
  30.4%
Not Classified
4
  17.4%
[1]
Measure Description: Diffuse Large B-Cell Lymphoma (DLBCL) staging involves molecular classification into subtypes. Germinal Center has shown typically better survival than Non-Germinal Center
1.Primary Outcome
Title Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria
Hide Description Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
52
(30.6 to 73.2)
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of participants
78
3.Secondary Outcome
Title Partial Response Rate
Hide Description The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
26
(10.2 to 48.4)
4.Secondary Outcome
Title Estimate of Progression-Free Survival
Hide Description Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.
Time Frame 2 years with the median follow-up of 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: Months
5.4
(3.8 to 10.2)
5.Secondary Outcome
Title Overall Survival
Hide Description This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.
Time Frame 2 years with the median follow-up of 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Median (95% Confidence Interval)
Unit of Measure: Months
10.2
(3.8 to 13.3)
6.Secondary Outcome
Title Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Hide Description The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.
Time Frame Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description:

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: percentage of patients
Lymphopenia 70
Anemia 26
Neutropenia 17
Thrombocytopenia 17
Lymphocytosis 4
Fatigue 13
Anorexia 9
Hyperglycemia 9
Urinary Tract Infection 9
Arthralgia 4
Atrial Fibrillation 4
Cognitive Disturbance 4
Generalized Muscle Weakness 4
Heart Failure 4
Hypoalbuminemia 4
Hyponatremia 4
Infusion Related Reaction 4
Myalgia 4
Nausea 4
Pleural Effusion 4
Maculopapular Rash 4
Sepsis 4
Skin Infection 4
Time Frame Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine, Rituximab
Hide Arm/Group Description

This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.

Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles

Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles

All-Cause Mortality
Bendamustine, Rituximab
Affected / at Risk (%)
Total   17/23 (73.91%) 
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine, Rituximab
Affected / at Risk (%)
Total   15/23 (65.22%) 
Blood and lymphatic system disorders   
Anemia * 1  1/23 (4.35%) 
Febrile neutropenia * 1  1/23 (4.35%) 
Cardiac disorders   
Heart failure * 1  1/23 (4.35%) 
Gastrointestinal disorders   
Duodenal hemorrhage * 1  1/23 (4.35%) 
Gastric hemorrhage * 1  1/23 (4.35%) 
General disorders   
Death NOS * 1  1/23 (4.35%) 
Fever * 1  2/23 (8.70%) 
Non-cardiac chest pain * 1  1/23 (4.35%) 
Infections and infestations   
Lung infection * 1  1/23 (4.35%) 
Sepsis * 1  2/23 (8.70%) 
Skin infection * 1  1/23 (4.35%) 
Urinary tract infection * 1  3/23 (13.04%) 
Investigations   
Neutrophil count decreased * 1  2/23 (8.70%) 
Platelet count decreased * 1  2/23 (8.70%) 
Creatinine increased * 1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Anorexia * 1  2/23 (8.70%) 
Hyponatremia * 1  1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/23 (4.35%) 
Nervous system disorders   
Cognitive Disturbance * 1  1/23 (4.35%) 
Stroke * 1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Pleural effusion * 1  1/23 (4.35%) 
Dyspnea * 1  2/23 (8.70%) 
Productive cough * 1  1/23 (4.35%) 
Vascular disorders   
Thromboembolic event * 1  1/23 (4.35%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bendamustine, Rituximab
Affected / at Risk (%)
Total   23/23 (100.00%) 
Blood and lymphatic system disorders   
Anemia * 1  20/23 (86.96%) 
Cardiac disorders   
Atrial fibrillation * 1  2/23 (8.70%) 
Chest pain - cardiac * 1  1/23 (4.35%) 
Gastrointestinal disorders   
Abdominal pain * 1  2/23 (8.70%) 
Colitis * 1  2/23 (8.70%) 
Constipation * 1  7/23 (30.43%) 
Diarrhea * 1  8/23 (34.78%) 
Dyspepsia * 1  3/23 (13.04%) 
Gastroesophageal reflux disease * 1  1/23 (4.35%) 
Mucositis oral * 1  1/23 (4.35%) 
Nausea * 1  11/23 (47.83%) 
Oral pain * 1  1/23 (4.35%) 
Vomiting * 1  6/23 (26.09%) 
General disorders   
Edema face * 1  1/23 (4.35%) 
Edema limbs * 1  4/23 (17.39%) 
Fatigue * 1  20/23 (86.96%) 
Fever * 1  3/23 (13.04%) 
Infusion related reaction * 1  4/23 (17.39%) 
Localized edema * 1  1/23 (4.35%) 
Pain * 1  2/23 (8.70%) 
Infections and infestations   
Infections and infestations - Other, specify * 1 [1]  1/23 (4.35%) 
Lip infection * 1  1/23 (4.35%) 
Mucosal infection * 1  2/23 (8.70%) 
Urinary tract infection * 1  6/23 (26.09%) 
Injury, poisoning and procedural complications   
Fall * 1  4/23 (17.39%) 
Investigations   
Activated partial thromboplastin time prolonged * 1  1/23 (4.35%) 
Alanine aminotransferase increased * 1  5/23 (21.74%) 
Alkaline phosphatase increased * 1  13/23 (56.52%) 
Aspartate aminotransferase increased * 1  14/23 (60.87%) 
Blood bilirubin increased * 1  3/23 (13.04%) 
Cardiac troponin I increased * 1  1/23 (4.35%) 
Creatinine increased * 1  10/23 (43.48%) 
Ejection fraction decreased * 1  1/23 (4.35%) 
INR increased * 1  1/23 (4.35%) 
Lymphocyte count decreased * 1  17/23 (73.91%) 
Neutrophil count decreased * 1  10/23 (43.48%) 
Platelet count decreased * 1  15/23 (65.22%) 
Weight loss * 1  7/23 (30.43%) 
White blood cell decreased * 1  14/23 (60.87%) 
Lymphocyte count increased * 1  1/23 (4.35%) 
Metabolism and nutrition disorders   
Alkalosis * 1  1/23 (4.35%) 
Anorexia * 1  14/23 (60.87%) 
Dehydration * 1  4/23 (17.39%) 
Hypercalcemia * 1  3/23 (13.04%) 
Hyperglycemia * 1  10/23 (43.48%) 
Hyperkalemia * 1  6/23 (26.09%) 
Hypermagnesemia * 1  6/23 (26.09%) 
Hypernatremia * 1  2/23 (8.70%) 
Hyperuricemia * 1  1/23 (4.35%) 
Hypoalbuminemia * 1  19/23 (82.61%) 
Hypocalcemia * 1  10/23 (43.48%) 
Hypokalemia * 1  10/23 (43.48%) 
Hypomagnesemia * 1  9/23 (39.13%) 
Hyponatremia * 1  10/23 (43.48%) 
Hypophosphatemia * 1  6/23 (26.09%) 
Metabolism and nutrition disorders - Other, specify * 1 [2]  1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  1/23 (4.35%) 
Back pain * 1  2/23 (8.70%) 
Generalized muscle weakness * 1  2/23 (8.70%) 
Muscle weakness lower limb * 1  1/23 (4.35%) 
Myalgia * 1  2/23 (8.70%) 
Pain in extremity * 1  4/23 (17.39%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify * 1 [3]  1/23 (4.35%) 
Tumor pain * 1  1/23 (4.35%) 
Nervous system disorders   
Dizziness * 1  4/23 (17.39%) 
Dysgeusia * 1  2/23 (8.70%) 
Headache * 1  1/23 (4.35%) 
Hypersomnia * 1  1/23 (4.35%) 
Lethargy * 1  1/23 (4.35%) 
Nervous system disorders - Other, specify * 1 [4]  1/23 (4.35%) 
Paresthesia * 1  1/23 (4.35%) 
Psychiatric disorders   
Confusion * 1  2/23 (8.70%) 
Depression * 1  1/23 (4.35%) 
Insomnia * 1  2/23 (8.70%) 
Restlessness * 1  1/23 (4.35%) 
Renal and urinary disorders   
Hemoglobinuria * 1  1/23 (4.35%) 
Proteinuria * 1  3/23 (13.04%) 
Urinary frequency * 1  2/23 (8.70%) 
Respiratory, thoracic and mediastinal disorders   
Bronchial obstruction * 1  1/23 (4.35%) 
Cough * 1  2/23 (8.70%) 
Dyspnea * 1  6/23 (26.09%) 
Pleural effusion * 1  3/23 (13.04%) 
Voice alteration * 1  1/23 (4.35%) 
Skin and subcutaneous tissue disorders   
Dry skin * 1  1/23 (4.35%) 
Pain of skin * 1  1/23 (4.35%) 
Rash acneiform * 1  3/23 (13.04%) 
Rash maculo-papular * 1  2/23 (8.70%) 
Skin ulceration * 1  1/23 (4.35%) 
Vascular disorders   
Flushing * 1  1/23 (4.35%) 
Hypertension * 1  3/23 (13.04%) 
Hypotension * 1  2/23 (8.70%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
[1]
Infection:viral
[2]
Elevated LDH
[3]
no description given
[4]
myoclonic spasms
The planned interim analysis was designed for futility (if ORR is less than 13/23 patients). It passed the futility criteria, but based on the survival rate at the time of interim analysis, the investigators decided to terminate the trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
EMail: Robin_V_Johnson@med.unc.edu
Layout table for additonal information
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01234467     History of Changes
Other Study ID Numbers: LCCC 1011
10-1405 ( Other Identifier: Office of Human Research Ethics )
First Submitted: November 2, 2010
First Posted: November 4, 2010
Results First Submitted: February 17, 2017
Results First Posted: April 26, 2017
Last Update Posted: May 24, 2017