Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes

Completed · Phase 1/Phase 2

Conditions studied: Leukemia, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT00075010

Run by

M.D. Anderson Cancer Center

People needed

54

Starts

2004-01-23

Expected to finish

2006-11-08

Last updated by the study team

2018-11-15

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

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.

Where it is running

• M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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