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PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT00303953
Recruitment Status : Completed
First Posted : March 17, 2006
Results First Posted : September 19, 2012
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Intervention Drug: belinostat
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PXD101
Hide Arm/Group Description Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Period Title: Overall Study
Started 22
Eligible 21
Eligible and Treated 20
Completed 3
Not Completed 19
Reason Not Completed
Ineligible             1
Death             1
Adverse Event             4
Lack of Efficacy             12
Physician Decision             1
Arm/Group Title PXD101
Hide Arm/Group Description Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
68.9
(51.6 to 82.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
19
  95.0%
Unknown or Not Reported
1
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
19
  95.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Assess Number of Patients Who Achieve Confirmed and Unconfirmed Complete Response (CR) or Partial Response (PR)
Hide Description Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the SPD for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.
Time Frame assessed at week 8, and every 3 months for 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in assessing response estimates.
Arm/Group Title PXD101
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 0
Complete Response Unconfirmed (CRU) 0
Partial Response (PR) 0
No response 20
2.Secondary Outcome
Title Overall Survival
Hide Description Measured from time of registration to death, or last contact date
Time Frame assessed every 3 months for 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients were included in the analyses.
Arm/Group Title PXD101
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: years
0.9
(0.2 to 2.3)
3.Secondary Outcome
Title Progression-free Survival
Hide Description Measured from date of registration to time of first documentation of progression or death, or last contact date. Progression is defined as a 50% increase in sum of products of greatest diameters (SPD) of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline; appearance of a new lesion/site; unequivocal progression of non-measurable disease in the opinion of the treating physician; death due to disease without prior documentation of progression.
Time Frame assessed at week 8, then every 3 months for 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only eligible patients were included in the analyses.
Arm/Group Title PXD101
Hide Arm/Group Description:
Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
Overall Number of Participants Analyzed 20
Median (95% Confidence Interval)
Unit of Measure: years
0.2
(0.1 to 0.3)
Time Frame After every cycle while on protocol treatment, for a maximum of 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PXD101
Hide Arm/Group Description Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
All-Cause Mortality
PXD101
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PXD101
Affected / at Risk (%)
Total   3/20 (15.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  1/20 (5.00%) 
Gastrointestinal disorders   
Diarrhea  1  1/20 (5.00%) 
Nausea  1  1/20 (5.00%) 
Vomiting  1  1/20 (5.00%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  1/20 (5.00%) 
Investigations   
Neutrophils/granulocytes (ANC/AGC)  1  1/20 (5.00%) 
Platelets  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PXD101
Affected / at Risk (%)
Total   18/20 (90.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  7/20 (35.00%) 
Cardiac disorders   
Supraventricular and nodal arrhythmia - Atrial fibrillation  1  1/20 (5.00%) 
Gastrointestinal disorders   
Constipation  1  2/20 (10.00%) 
Diarrhea  1  4/20 (20.00%) 
Flatulence  1  1/20 (5.00%) 
Heartburn/dyspepsia  1  1/20 (5.00%) 
Nausea  1  8/20 (40.00%) 
Pain - Abdomen NOS  1  4/20 (20.00%) 
Vomiting  1  4/20 (20.00%) 
General disorders   
Edema: limb  1  2/20 (10.00%) 
Fatigue (asthenia, lethargy, malaise)  1  8/20 (40.00%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC lt1.0 x 10e9/L)  1  1/20 (5.00%) 
Injection site reaction/extravasation changes  1  2/20 (10.00%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS  1  1/20 (5.00%) 
Infection with unknown ANC - Urinary tract NOS  1  1/20 (5.00%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  5/20 (25.00%) 
AST, SGOT (serum glutamic oxaloacetic transaminase)  1  6/20 (30.00%) 
Alkaline phosphatase  1  4/20 (20.00%) 
Bilirubin (hyperbilirubinemia)  1  1/20 (5.00%) 
Cholesterol, serum-high (hypercholesterolemia)  1  1/20 (5.00%) 
Creatinine  1  4/20 (20.00%) 
Leukocytes (total WBC)  1  2/20 (10.00%) 
Lymphopenia  1  2/20 (10.00%) 
Metabolic/Laboratory-Other (Specify)  1  2/20 (10.00%) 
Platelets  1  5/20 (25.00%) 
Prolonged QTc interval  1  1/20 (5.00%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  2/20 (10.00%) 
Anorexia  1  3/20 (15.00%) 
Calcium, serum-high (hypercalcemia)  1  1/20 (5.00%) 
Calcium, serum-low (hypocalcemia)  1  1/20 (5.00%) 
Dehydration  1  1/20 (5.00%) 
Glucose, serum-high (hyperglycemia)  1  2/20 (10.00%) 
Potassium, serum-high (hyperkalemia)  1  1/20 (5.00%) 
Sodium, serum-high (hypernatremia)  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  1/20 (5.00%) 
Pain - Back  1  1/20 (5.00%) 
Pain - Extremity-limb  1  1/20 (5.00%) 
Pain - Joint  1  1/20 (5.00%) 
Pain - Muscle  1  2/20 (10.00%) 
Nervous system disorders   
Dizziness  1  3/20 (15.00%) 
Neurology-Other (Specify)  1  1/20 (5.00%) 
Neuropathy: sensory  1  1/20 (5.00%) 
Pain - Head/headache  1  1/20 (5.00%) 
Psychiatric disorders   
Insomnia  1  1/20 (5.00%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)  1  1/20 (5.00%) 
Dyspnea (shortness of breath)  1  1/20 (5.00%) 
Vascular disorders   
Flushing  1  1/20 (5.00%) 
Hot flashes/flushes  1  2/20 (10.00%) 
Hypertension  1  1/20 (5.00%) 
Hypotension  1  2/20 (10.00%) 
Phlebitis (including superficial thrombosis)  1  2/20 (10.00%) 
Vascular-Other (Specify)  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Name/Title: Lymphoma Committee Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00303953     History of Changes
Other Study ID Numbers: NCI-2009-01096
NCI-2009-01096 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000462614
S0520 ( Other Identifier: Southwest Oncology Group )
S0520 ( Other Identifier: CTEP )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2006
First Posted: March 17, 2006
Results First Submitted: February 28, 2012
Results First Posted: September 19, 2012
Last Update Posted: May 12, 2014