Vorinostat and Idarubicin in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndromes
Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
Eligibility Criteria
Inclusion Criteria: Patients must have histologically or cytologically confirmed relapsed/refractory acute myelogenous leukemia, acute lymphocytic leukemia, myelodysplastic syndrome or blastic phase chronic myelogenous leukemia. Patients that have received cumulative doses (or its equivalent to other anthracycline) of more than 290 mg/m^2 of idarubicin will be excluded from the study. No other limitations in terms of number of prior therapies or type of therapies apply to this study. ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% Total bilirubin ≤ 2 mg/dL AST and ALT ≤ 2.5 times upper limit of normal Creatinine ≤ 2 mg/dL LVEF ≥ 50% Not nursing or pregnant Negative pregnancy test Fertile patients must use effective contraception At least 2 weeks since prior chemotherapy and recovered, unless there is evidence of rapidly progressive disease, at least 24 hours since prior hydroxyurea for rapidly proliferating disease At least 2 weeks since prior imatinib mesylate At least 2 weeks since prior histone deacetylase inhibitors, including valproic acid Maximum cumulative dose of prior idarubicin or equivalent anthracycline drug ≤ 290 mg/m2 No concurrent epoetin alfa or hematopoietic colony-stimulating factors during the first course of study therapy No concurrent prophylactic hematopoietic colony-stimulating factors Myelodysplastic syndromes requiring treatment, previously treated with either azacytidine or decitabine, unless it was contraindicated; blastic phase chronic myelogenous leukemia; failed prior imatinib mesylate-based therapy Patients with MDS should have received therapy with either 5-azacytidine or 5-aza-2'-deoxycytidine, unless the patient had a contraindication to such therapy, and should require therapy. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Patients with clinical evidence of CNS disease should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. No unstable angina pectoris Considered ineligible for or refused potentially curative therapy, including allogeneic stem cell transplantation, with or without standard induction therapy No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat (SAHA) or other agents used in this study No ongoing or active infection No symptomatic congestive heart failure No cardiac arrhythmia No other uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other concurrent investigational agents No other concurrent anticancer agents or therapies No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Arm I (vorinostat, idarubicin)
Arm II (vorinostat, idarubicin)
Patients receive oral SAHA three times daily on days 1-14 and idarubicin IV over 15 minutes once daily on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy or who reach the maximum cumulative dose of idarubicin or an equivalent anthracycline and achieve clinical benefit may continue treatment with SAHA alone 3 times daily on days 1-14 of each course, in the absence of disease progression or unacceptable toxicity.
Patients receive oral SAHA three times daily and idarubicin IV over 15 minutes once daily on days 1-3. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy or who reach the maximum cumulative dose of idarubicin or an equivalent anthracycline and achieve clinical benefit may continue treatment with SAHA alone 3 times daily on days 1-14 of each course, in the absence of disease progression or unacceptable toxicity.