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Trial record 65 of 1148 for:    Oral Cancer | ( Map: Canada )

Sunitinib in Treating Patients With Relapsed or Refractory Diffuse or Mediastinal 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: NCT00392496
Recruitment Status : Completed
First Posted : October 26, 2006
Results First Posted : December 12, 2013
Last Update Posted : May 15, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Stage IV Adult Diffuse Large Cell Lymphoma
Intervention Drug: sunitinib malate
Enrollment 19
Recruitment Details This trial was centrally activated on November 8, 2006 and closed to accrual on March 24, 2009. Patients were recruited from 5 cancer centres in Canada
Pre-assignment Details  
Arm/Group Title Arm I
Hide Arm/Group Description This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 19
Completed 19
Not Completed 0
Arm/Group Title Arm I
Hide Arm/Group Description This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
Two patients who were determined as ineligible were excluded from all analyses
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
65
(34 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
7
  41.2%
Male
10
  58.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 17 participants
17
1.Primary Outcome
Title Objective Tumor Response
Hide Description It is defined as per the Report of the International workshop to standardize response criteria for non-Hodgkin’s lymphoma and reviewed independently
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
patients evaluable for response
Arm/Group Title Arm I
Hide Arm/Group Description:
This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%)
Total   13/17 (76.47%) 
Cardiac disorders   
Grade 2 Left Ventricular Systolic Dysfunction  1  1/17 (5.88%) 
Gastrointestinal disorders   
Grade 2 dysphagia and hypothyroidism  1  1/17 (5.88%) 
Hospitalization for grade 3 GI Bleed  1  1/17 (5.88%) 
General disorders   
Grade 4 fatigue  1  1/17 (5.88%) 
Death not associated with CTCAE term  1  3/17 (17.65%) 
Grade 2 Rigors/chills  1  1/17 (5.88%) 
Investigations   
Grade 2 Hypothyroidism  1  1/17 (5.88%) 
Grade 3 ALT, gr 2 AST and gr 2 alkaline phosphatase  1  1/17 (5.88%) 
Hospitalization for gr 4 platelets and gr 3 hemoglobin  1  1/17 (5.88%) 
Grade 3 AST  1  1/17 (5.88%) 
Nervous system disorders   
Grade 2 somnolence  1  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Hospitalization for Grade 3 dyspnea  1  1/17 (5.88%) 
Skin and subcutaneous tissue disorders   
Hospitalization for infected lymphoma lesion (skin: cellulitis grade 5)  1  1/17 (5.88%) 
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%
Arm I
Affected / at Risk (%)
Total   17/17 (100.00%) 
Blood and lymphatic system disorders   
Hemorrhage pulmonary Nose  1  3/17 (17.65%) 
Hemorrhage, GI Oral cavity  1  1/17 (5.88%) 
Hemorrhage, GI Stomach  1  1/17 (5.88%) 
Edema: limb  1  4/17 (23.53%) 
Lymphatics - Other  1  2/17 (11.76%) 
Cardiac disorders   
Supraventricular arrhythmia Sinus tachycardia  1  1/17 (5.88%) 
Hypertension  1  4/17 (23.53%) 
Hypotension  1  1/17 (5.88%) 
Left ventricular systolic dysfunction  1  1/17 (5.88%) 
Pericardial effusion  1  1/17 (5.88%) 
Endocrine disorders   
Hypothyroidism  1  2/17 (11.76%) 
Eye disorders   
Diplopia  1  1/17 (5.88%) 
Gastrointestinal disorders   
Anorexia  1  11/17 (64.71%) 
Constipation  1  9/17 (52.94%) 
Dehydration  1  3/17 (17.65%) 
Diarrhea  1  8/17 (47.06%) 
Distension  1  1/17 (5.88%) 
Dry mouth  1  3/17 (17.65%) 
Dysphagia  1  2/17 (11.76%) 
Heartburn  1  8/17 (47.06%) 
Mucositis (clinical exam) Oral cavity  1  4/17 (23.53%) 
Mucositis (functional/symptomatic) Oral cavity  1  4/17 (23.53%) 
Mucositis (functional/symptomatic) Pharynx  1  1/17 (5.88%) 
Nausea  1  9/17 (52.94%) 
Taste alteration  1  4/17 (23.53%) 
Vomiting  1  7/17 (41.18%) 
GI - Other  1  2/17 (11.76%) 
General disorders   
Fatigue  1  14/17 (82.35%) 
Fever  1  4/17 (23.53%) 
Insomnia  1  3/17 (17.65%) 
Rigors/chills  1  2/17 (11.76%) 
Sweating  1  2/17 (11.76%) 
Pain Abdomen NOS  1  6/17 (35.29%) 
Pain Back  1  5/17 (29.41%) 
Pain Bladder  1  1/17 (5.88%) 
Pain Bone  1  1/17 (5.88%) 
Pain Chest/thorax NOS  1  1/17 (5.88%) 
Pain Extremity-limb  1  3/17 (17.65%) 
Pain Head/headache  1  3/17 (17.65%) 
Pain Joint  1  3/17 (17.65%) 
Pain Lymph node  1  1/17 (5.88%) 
Pain Middle ear  1  1/17 (5.88%) 
Pain Muscle  1  2/17 (11.76%) 
Pain Oral cavity  1  4/17 (23.53%) 
Pain Pain NOS  1  1/17 (5.88%) 
Pain Tumor pain  1  2/17 (11.76%) 
Cough  1  6/17 (35.29%) 
Dyspnea  1  8/17 (47.06%) 
Pleural effusion  1  2/17 (11.76%) 
Voice changes  1  2/17 (11.76%) 
Pulmonary - Other  1  1/17 (5.88%) 
Infections and infestations   
Infection with normal ANC Bladder  1  1/17 (5.88%) 
Infection with normal ANC Lung  1  1/17 (5.88%) 
Infection with normal ANC Pelvis NOS  1  1/17 (5.88%) 
Infection with normal ANC Skin  1  1/17 (5.88%) 
Infection with normal ANC Upper airway NOS  1  1/17 (5.88%) 
Infection with unknown ANC Blood  1  1/17 (5.88%) 
Infection with unknown ANC Lip/perioral  1  1/17 (5.88%) 
Infection - Other  1  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/17 (5.88%) 
Gait/walking  1  1/17 (5.88%) 
Muscle weakness Whole body/generalized  1  1/17 (5.88%) 
Nervous system disorders   
Confusion  1  1/17 (5.88%) 
Mood alteration Anxiety  1  1/17 (5.88%) 
Mood alteration Depression  1  1/17 (5.88%) 
Neuropathy-sensory  1  7/17 (41.18%) 
Somnolence  1  1/17 (5.88%) 
Renal and urinary disorders   
Urinary frequency  1  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Bronchospasm  1  1/17 (5.88%) 
Skin and subcutaneous tissue disorders   
Decubitus  1  1/17 (5.88%) 
Hand-foot  1  1/17 (5.88%) 
Nail changes  1  1/17 (5.88%) 
Pruritus  1  1/17 (5.88%) 
Rash  1  1/17 (5.88%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  1/17 (5.88%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Rena Buckstein
Organization: Sunnybrook Health Sciences Centre
Phone: 416-480-5847
EMail: rena.buckstein@sunnybrook.ca
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00392496     History of Changes
Other Study ID Numbers: NCI-2009-00692
NCI-2009-00692 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000652059
NCIC-182 ( Other Identifier: National Cancer Institute of Canada Clinical Trials Group )
NCIC-182 ( Other Identifier: CTEP )
First Submitted: October 25, 2006
First Posted: October 26, 2006
Results First Submitted: October 21, 2013
Results First Posted: December 12, 2013
Last Update Posted: May 15, 2014