Phase II 5-Azacytidine Plus VPA Plus ATRA
Myelodysplastic Syndrome, Acute Myelogenous Leukemia
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Combination Chemotherapy, MDS, High-Risk Myelodysplastic Syndrome, AML, Acute myelogenous leukemia, valproic acid, VPA, Depakene, 5-azacytidine, 5-aza, Azacitidine, 5-AZC, Vidaza, AZA-CR, Ladakamycin, NSC-102816, All-trans retinoic acid, ATRA, Tretinoin, Vesanoid
Eligibility Criteria
Inclusion Criteria: Patients with refractory or relapsed: acute myelogenous leukemia (AML), and myelodysplastic syndrome (MDS) (bone marrow blasts > or = 10%) are eligible. Untreated patients older than 60 years of age with AML or MDS (bone marrow blasts > or = 10%) who refuse or are not eligible for front-line chemotherapy, are eligible. Performance status of < or = 2 by the Eastern Cooperative Oncology Group (ECOG) scale. Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of University of Texas M D Anderson Cancer Center (UTMDACC). Age > 2 years. Valproic acid has been associated with a higher rate of severe liver toxicity in children younger than 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. Adequate liver function (bilirubin of < 2mg/dL, SGPT < 3 * ULN) and renal function (creatinine < 2mg/dL). Women of childbearing potential must practice contraception. Men and women must continue birth control for the duration of the trial. Patients with relapsed /refractory disease with inv16, t(8;21) or t(15;17) are eligible. Exclusion Criteria: Nursing and pregnant females are excluded. Patients with active and uncontrolled infections are excluded. Patients already receiving valproic acid or receiving other anticonvulsants will be excluded. Untreated patients younger than 60 years will not be candidates for this study. Patients with untreated disease inv16, t(8;21) or t(15;17) will be excluded.
Sites / Locations
- The University of Texas M.D. Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
VPA + 5-aza + ATRA
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.