Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
Phase I/II Study of 5-aza-2'-Deoxycytidine and Valproic Acid in Patients With Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
1 other identifier
interventional
54
1 country
1
Brief Summary
Valproic acid is a medication that is currently used in the prevention of seizures, bipolar disorder, and migraine headaches. Researchers hope that it may improve the effects of decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 leukemia
Started Jan 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2003
CompletedFirst Posted
Study publicly available on registry
December 31, 2003
CompletedStudy Start
First participant enrolled
January 23, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2006
CompletedNovember 15, 2018
November 1, 2018
2.8 years
December 29, 2003
November 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) of Valproic Acid + Decitabine
MTD is the dose level at which less than two participants develop a dose limiting toxicity (DLT). Response evaluated after completing first cycle, 4-8 weeks of therapy.
Up to 8 weeks of therapy
Study Arms (1)
Decitabine + Valproic acid
EXPERIMENTALDecitabine 15 mg/m\^2 by vein over 1 hour times 10 days
Interventions
15 mg/m\^2 by vein over 1 hour times 10 days
Eligibility Criteria
You may qualify if:
- FOR PHASE I COMPONENT OF THE STUDY: Patients with refractory or relapsed: acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and myelodysplastic syndrome (MDS) are eligible. Patients with chronic lymphocytic leukemia (CLL) are eligible if fludarabine based therapy has failed. Patients with chronic myeloid leukemia (CML) are eligible if they have documented hematologic resistance to imatinib mesylate or have not achieved or lost any cytogenetic response to imatinib mesylate after 12 months of therapy.
- Untreated patients older than 60 years of age with AML or MDS who refuse or are not eligible for frontline chemotherapy, are eligible.
- Performance status of =/\< 2 by the ECOG scale.
- Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC.
- Age \> 2 years.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy. Imatinib mesylate (Gleevec) and anagrelide must also be stopped 2 weeks prior to entering this study.
- Adequate liver function (bilirubin of \< 2mg%, SGPT \< 3 x ULN) and renal function (creatinine \< 2mg%).
- Women of childbearing potential must practice contraception. Men and women must continue birth control for the duration of the trial.
You may not qualify if:
- Nursing and pregnant females are excluded.
- Patients with active and uncontrolled infections are excluded.
- Patients with a known ornithine transcarbamylase disorder, history of unexplained coma or a family history of ornithine transcarbamylase disorder are excluded from this study.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, pancreatitis, psychiatric illness that would limit compliance with study requirements.
- Patients with history of hepatitis B, C, alcoholic liver disease or evidence of hepatopathy will be excluded.
- Patients already receiving valproic acid or receiving other anticonvulsivants will be excluded.
- Untreated patients younger than 60 years will not be candidates for this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eisai Inc.collaborator
Study Sites (1)
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Garcia-Manero G, Kantarjian HM, Sanchez-Gonzalez B, Yang H, Rosner G, Verstovsek S, Rytting M, Wierda WG, Ravandi F, Koller C, Xiao L, Faderl S, Estrov Z, Cortes J, O'brien S, Estey E, Bueso-Ramos C, Fiorentino J, Jabbour E, Issa JP. Phase 1/2 study of the combination of 5-aza-2'-deoxycytidine with valproic acid in patients with leukemia. Blood. 2006 Nov 15;108(10):3271-9. doi: 10.1182/blood-2006-03-009142. Epub 2006 Aug 1.
PMID: 16882711DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guillermo Garcia-Manero, M.D.
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2003
First Posted
December 31, 2003
Study Start
January 23, 2004
Primary Completion
November 8, 2006
Study Completion
November 8, 2006
Last Updated
November 15, 2018
Record last verified: 2018-11