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Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes

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ClinicalTrials.gov Identifier: NCT00118287
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : May 24, 2017
Last Update Posted : May 24, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bart Scott, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions de Novo Myelodysplastic Syndromes
Previously Treated Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
Interventions Drug: azacitidine
Biological: etanercept
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Chemotherapy, Chemoprotection)
Hide Arm/Group Description

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC

Period Title: Overall Study
Started 32
Completed 30
Not Completed 2
Reason Not Completed
Intracranial haemorrhage             1
Muscle pain             1
Arm/Group Title Treatment (Chemotherapy, Chemoprotection)
Hide Arm/Group Description

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
69
(31 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
11
  34.4%
Male
21
  65.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
31
  96.9%
Unknown or Not Reported
1
   3.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.1%
White
30
  93.8%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
Hide Description Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
Time Frame Up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Chemotherapy, Chemoprotection)
Hide Arm/Group Description:

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC

Overall Number of Participants Analyzed 32
Measure Type: Count of Participants
Unit of Measure: Participants
Erythroid response
14
  43.8%
Platelet response
8
  25.0%
Neutrophil response
1
   3.1%
No response
7
  21.9%
Withdrawn from study
2
   6.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Chemotherapy, Chemoprotection)
Hide Arm/Group Description

Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.

azacitidine: Given SC or IV

etanercept: Given SC

All-Cause Mortality
Treatment (Chemotherapy, Chemoprotection)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Treatment (Chemotherapy, Chemoprotection)
Affected / at Risk (%)
Total   5/32 (15.63%) 
Blood and lymphatic system disorders   
Splenic rupture with splenectomy  1/32 (3.13%) 
Cardiac disorders   
Cardiopulmonary arrest resulting in death  1/32 (3.13%) 
Hepatobiliary disorders   
Gall Bladder removal with benign mass  1/32 (3.13%) 
Infections and infestations   
Endocarditis  1/32 (3.13%) 
Nervous system disorders   
CNS hemorrhages  3/32 (9.38%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  1/32 (3.13%) 
Hemoptysis and fever  1/32 (3.13%) 
Pulmonary nodule  1/32 (3.13%) 
Dyspnea  1/32 (3.13%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Chemotherapy, Chemoprotection)
Affected / at Risk (%)
Total   26/32 (81.25%) 
Blood and lymphatic system disorders   
Anemia  19/32 (59.38%) 
Coagulopathy  3/32 (9.38%) 
Febrile neutropenia  7/32 (21.88%) 
Leukopenia  15/32 (46.88%) 
Lymphopenia  16/32 (50.00%) 
Transfusion reaction  3/32 (9.38%) 
Petechia  2/32 (6.25%) 
Cardiac disorders   
Atrial fibrillation/flutter  3/32 (9.38%) 
Congestive heart failure  6/32 (18.75%) 
Elevated cardiac enzymes  3/32 (9.38%) 
Hypertension  2/32 (6.25%) 
Hypotension  4/32 (12.50%) 
Gastrointestinal disorders   
Diverticulitis  2/32 (6.25%) 
Ileus  2/32 (6.25%) 
Rectal or GI bleeding  6/32 (18.75%) 
Nausea/Vomiting  2/32 (6.25%) 
General disorders   
Mouth/Gum Bleeding  2/32 (6.25%) 
Fatigue  11/32 (34.38%) 
Weakness  2/32 (6.25%) 
Hepatobiliary disorders   
Gallstones  2/32 (6.25%) 
Hematuria  9/32 (28.13%) 
Investigations   
Hyperbilirubinemia  3/32 (9.38%) 
Neutropenia  17/32 (53.13%) 
Thrombocytopenia  17/32 (53.13%) 
Metabolism and nutrition disorders   
Dehydration, 1 with diarrhea  2/32 (6.25%) 
Hyperglycemia  3/32 (9.38%) 
Hyperglycemia  2/32 (6.25%) 
Hyponatremia  8/32 (25.00%) 
Musculoskeletal and connective tissue disorders   
Arthritis, Joint pain  5/32 (15.63%) 
Musculoskeletal pain  11/32 (34.38%) 
Compression fractures  2/32 (6.25%) 
Gout  2/32 (6.25%) 
Limited upper extremity function, after injury  2/32 (6.25%) 
Renal and urinary disorders   
Renal failure  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia  6/32 (18.75%) 
Dyspnea on exertion  3/32 (9.38%) 
Hypoxia  7/32 (21.88%) 
Pleural effusions  2/32 (6.25%) 
Hemoptysis  2/32 (6.25%) 
Skin and subcutaneous tissue disorders   
Bleeding from cuts  2/32 (6.25%) 
Hives, urticaria  3/32 (9.38%) 
Squamos cell carcinoma removal  2/32 (6.25%) 
Rash  2/32 (6.25%) 
Vascular disorders   
Hematoma  2/32 (6.25%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bart Scott
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-1990
EMail: bscott@fredhutch.org
Layout table for additonal information
Responsible Party: Bart Scott, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00118287    
Other Study ID Numbers: 1926.00
NCI-2011-01818 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 8, 2005
First Posted: July 11, 2005
Results First Submitted: April 17, 2017
Results First Posted: May 24, 2017
Last Update Posted: May 24, 2017