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Phase II 5-Azacytidine Plus VPA Plus ATRA

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: NCT00326170
Recruitment Status : Completed
First Posted : May 16, 2006
Results First Posted : July 11, 2011
Last Update Posted : June 15, 2012
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Interventions Drug: 5-Azacytidine (5-aza)
Drug: Valproic Acid
Drug: All-Trans Retinoic Acid (ATRA)
Enrollment 34
Recruitment Details Recruitment Period: 06/10/05 through 11/17/06. All participants recruited at UT MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title VPA + 5-aza + ATRA
Hide Arm/Group Description Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
Period Title: Overall Study
Started 34
Completed 34
Not Completed 0
Arm/Group Title VPA + 5-aza + ATRA
Hide Arm/Group Description Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 34 participants
70
(49 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
11
  32.4%
Male
23
  67.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Number of Participants With Response
Hide Description Clinical activity of combination defined as: Complete Response (CR), bone marrow with 5% or fewer blasts and peripheral blood count with an absolute neutrophil count of 10^9/L or more and platelet count of 100x10^9 or more; Complete response without platelets (CRp), a complete response except for a platelet count less than 100x10^9 and transfusion independent; and Bone Marrow (BM) Response, bone marrow blast of 5% or less but without meeting the peripheral blood count criteria for (CR) or (CRp).
Time Frame Up to 12 cycles of treatment (28 day cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VPA + 5-aza + ATRA
Hide Arm/Group Description:
Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
Overall Number of Participants Analyzed 34
Measure Type: Number
Unit of Measure: Participants
CR 12
CRp 3
BM 7
Time Frame 2 Years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VPA + 5-aza + ATRA
Hide Arm/Group Description Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
All-Cause Mortality
VPA + 5-aza + ATRA
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
VPA + 5-aza + ATRA
Affected / at Risk (%) # Events
Total   31/34 (91.18%)    
Blood and lymphatic system disorders   
Thrombocytopenia † 1  4/34 (11.76%)  4
Pancytopenia † 1  2/34 (5.88%)  2
Edema † 1  1/34 (2.94%)  2
Cardiac disorders   
Atrial Fibrillation † 1  1/34 (2.94%)  1
Gastrointestinal disorders   
Diarrhea † 1  4/34 (11.76%)  4
Dehydration † 1  2/34 (5.88%)  2
Constipation † 1  1/34 (2.94%)  1
General disorders   
Death † 1  11/34 (32.35%)  11
Fatigue † 1  7/34 (20.59%)  8
Pain † 1  4/34 (11.76%)  4
Fever † 1  1/34 (2.94%)  1
Infections and infestations   
Infection † 1  8/34 (23.53%)  8
Metabolism and nutrition disorders   
Hyperglycemia † 1  1/34 (2.94%)  1
Nervous system disorders   
Somnolence † 1  10/34 (29.41%)  11
Syncope † 1  2/34 (5.88%)  2
Confusion † 1  4/34 (11.76%)  4
Skin and subcutaneous tissue disorders   
Rash † 1  2/34 (5.88%)  2
Vascular disorders   
Hemorrhage † 1  2/34 (5.88%)  2
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
VPA + 5-aza + ATRA
Affected / at Risk (%) # Events
Total   11/34 (32.35%)    
Gastrointestinal disorders   
Vomiting † 1  1/34 (2.94%)  1
General disorders   
Weakness † 1  5/34 (14.71%)  5
Fatigue † 1  1/34 (2.94%)  1
Fever † 1  1/34 (2.94%)  1
Nervous system disorders   
Confusion † 1  4/34 (11.76%)  4
Somnolence † 1  2/34 (5.88%)  2
Renal and urinary disorders   
Nocturia † 1  1/34 (2.94%)  1
Respiratory, thoracic and mediastinal disorders   
Cough † 1  1/34 (2.94%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[Not Specified]
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: Guillermo Garcia-Manero, MD / Associate Professor
Organization: UT MD Anderson Cancer Center
Phone: 713-792-7305
EMail: eharriso@mdanderson.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00326170    
Obsolete Identifiers: NCT01575691
Other Study ID Numbers: 2004-0799
First Submitted: May 12, 2006
First Posted: May 16, 2006
Results First Submitted: June 6, 2011
Results First Posted: July 11, 2011
Last Update Posted: June 15, 2012