Status:
COMPLETED
Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Eisai Inc.
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
2+ years
Phase:
PHASE1
PHASE2
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...
Detailed Description
Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. It has been shown that both DNA methylation and histone deacetylation work together in affecting gene...
Eligibility Criteria
Inclusion
- 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.
- INCLUSION OF PHASE II PORTION OF THE STUDY: As in the phase I portion but only patients with AML or high-risk MDS (blasts \> or = 10%), including untreated patients older than 60 years of age with AML or MDS who refuse or are not eligible for frontline chemotherapy, will be eligible in this portion of the study.
Exclusion
- 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.
Key Trial Info
Start Date :
January 23 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2006
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00075010
Start Date
January 23 2004
End Date
November 8 2006
Last Update
November 15 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030