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Trial record 81 of 881 for:    "Reticulum Cell Sarcoma"

Phase 2 Study of Bexxar in Relapsed/Refractory DLCL

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: NCT00490009
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : February 28, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Corixa Corporation
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoma
Interventions Drug: Bexxar
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Potassium Iodide (KI)
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bexxar
Hide Arm/Group Description Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
Period Title: Overall Study
Started 9
Completed 9
Not Completed 0
Arm/Group Title Bexxar
Hide Arm/Group Description Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  33.3%
>=65 years
6
  66.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female 5
Male 4
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
1
  11.1%
Not Hispanic or Latino
8
  88.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  11.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
7
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
1
  11.1%
1.Primary Outcome
Title Clinical Response Rate
Hide Description Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bexxar
Hide Arm/Group Description:
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA-approved regimen for other indications.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
Clinical Response 2
Complete Response (CR) 0
Functional CR 1
PR 1
SD 6
PD 1
2.Secondary Outcome
Title Time to Progression (TTP)
Hide Description Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression.
Time Frame 1.5 months; 3 months; 6 months; or Not Progressed
Hide Outcome Measure Data
Hide Analysis Population Description
1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.
Arm/Group Title Bexxar
Hide Arm/Group Description:
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
1.5 months 1
3 months 2
6 months 2
Not Progressed 3
3.Secondary Outcome
Title Overall Survival (OS) Rate
Hide Description Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
Time Frame 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome.
Arm/Group Title Bexxar
Hide Arm/Group Description:
Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
37.5
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bexxar + Tylenol + Benadryl + SSKI
Hide Arm/Group Description Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV
All-Cause Mortality
Bexxar + Tylenol + Benadryl + SSKI
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bexxar + Tylenol + Benadryl + SSKI
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Neutropenia * 1  5/9 (55.56%)  5
Thromnocytopenia * 1  1/9 (11.11%)  1
Anemia-tachycardia * 1  1/9 (11.11%)  1
hypotension * 1  1/9 (11.11%)  1
Anemia * 1  1/9 (11.11%)  1
Leukocytoperia * 1  2/9 (22.22%)  2
Gastrointestinal disorders   
Nausea * 1  1/9 (11.11%)  1
Stricture * 1  1/9 (11.11%)  1
Vomitting * 1  1/9 (11.11%)  1
Stenosis (including anastomotic GI- Blilary tree) * 1  1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bexxar + Tylenol + Benadryl + SSKI
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  9/9 (100.00%)  9
High Neutrophil count * 1  1/9 (11.11%)  1
Leukocytoperia * 1  9/9 (100.00%)  9
Leukocytosis * 1  1/9 (11.11%)  1
Neutroperia * 1  7/9 (77.78%)  7
Thrombocytopenia * 1  9/9 (100.00%)  9
Ear and labyrinth disorders   
Loss of balance * 1  2/9 (22.22%)  2
Eye disorders   
Blurred visiom * 1  1/9 (11.11%)  1
Gastrointestinal disorders   
Constipation * 1  1/9 (11.11%)  1
Diarrehea * 1  1/9 (11.11%)  1
Loose Stools * 1  1/9 (11.11%)  1
Nausea * 1  2/9 (22.22%)  2
Upset Stomach * 1  1/9 (11.11%)  1
Small cold * 1 [1]  1/9 (11.11%)  1
General disorders   
Fatigue * 1  9/9 (100.00%)  9
Fatigue secondary to dexamethasone * 1  1/9 (11.11%)  1
Fever * 1  2/9 (22.22%)  2
Left side is sore * 1  1/9 (11.11%)  1
Leg Swelling during the day * 1  1/9 (11.11%)  1
Pain * 1 [2]  3/9 (33.33%)  3
Swelling * 1 [3]  4/9 (44.44%)  4
Investigations   
Renal insufficiency * 1 [4]  1/9 (11.11%)  1
Metabolism and nutrition disorders   
Low Potassium * 1  1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders   
Back pains * 1  5/9 (55.56%)  5
Joint Pain * 1  1/9 (11.11%)  1
Neck Pain * 1  1/9 (11.11%)  1
Numbness * 1 [5]  4/9 (44.44%)  4
Throbbing Intermittent * 1 [6]  4/9 (44.44%)  4
Nervous system disorders   
Dizziness * 1  2/9 (22.22%)  2
Foot Numbness * 1  1/9 (11.11%)  1
Lethargy * 1  2/9 (22.22%)  2
Memory Loss * 1  1/9 (11.11%)  1
Mild headaches * 1  1/9 (11.11%)  1
Respiratory, thoracic and mediastinal disorders   
Burning Throat after SSKI * 1  1/9 (11.11%)  1
Cough * 1  3/9 (33.33%)  3
Skin and subcutaneous tissue disorders   
Dry Skin * 1  1/9 (11.11%)  1
Neck Irritated * 1  2/9 (22.22%)  2
Rash * 1  1/9 (11.11%)  1
Skin Cancers * 1 [7]  1/9 (11.11%)  1
Vascular disorders   
Hypertension * 1 [8]  1/9 (11.11%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
(runny nose, tired)
[2]
within body
[3]
within the body (arms, legs, groin,etc)
[4]
Increase Creatinine
[5]
in legs and arms
[6]
within the groin area
[7]
sideburns, arms, all removed
[8]
(High BP ~155/103)
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: Susan J Knox, MD, Associate Professor of Radiation Oncology
Organization: Stanford University Medical Center
Phone: 650-725-2720
EMail: sknox@stanford.edu
Layout table for additonal information
Responsible Party: Susan Knox, Stanford University
ClinicalTrials.gov Identifier: NCT00490009     History of Changes
Other Study ID Numbers: IRB-10275
LYMNHL0019 ( Other Identifier: OnCore )
30978 ( Other Identifier: Stanford SPO )
First Submitted: June 20, 2007
First Posted: June 22, 2007
Results First Submitted: January 9, 2017
Results First Posted: February 28, 2017
Last Update Posted: March 30, 2017