Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia

Inclusion Criteria:

* Diagnosis of acute myeloid leukemia (AML), meeting one of the following criteria:

  * Relapsed or refractory disease (≥ 18 years of age)
  * Previously untreated disease (≥ 60 years of age)
* Secondary AML or therapy-related AML allowed
* No granulocytic sarcoma as the sole site of disease
* No active or relapsed CNS disease
* No advanced malignant solid tumors
* ECOG performance status 0-2
* Life expectancy \> 6 months (if patient has co-morbid illness)
* Total bilirubin \< 2.0 mg/dL
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine \< 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Patients with HIV infection are eligible provided the following criteria are met:

  * No history of AIDS
  * Has a sufficiently high CD4 count (\> 400/mm³)
  * Has low HIV viral loads (\< 30,000 copies/mL plasma)
  * Does not require anti-HIV therapy
* No uncontrolled active infection
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to decitabine or bortezomib that are not easily managed
* No hypersensitivity to boron or mannitol
* No concurrent uncontrolled illness including, but not limited to, any of the following:

  * Symptomatic congestive heart failure
  * Unstable or uncontrolled angina pectoris
  * Serious cardiac arrhythmia
  * Myocardial infarction within the past 6 months
  * New York Heart Association class III-IV heart failure
  * Severe uncontrolled ventricular arrhythmias
  * Acute ischemia or active conduction system abnormalities by ECG
* No serious medical or psychiatric illness or social situation that would preclude participation in this study
* No pre-existing neuropathy ≥ grade 2
* No other serious neurologic toxicity that would significantly increase the risk of complications from bortezomib therapy
* Recovered from prior therapy (toxicity \< grade 2)
* More than 14 days since prior investigational agents
* More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) or radiotherapy
* Prior decitabine or azacitidine for myelodysplastic syndromes (MDS) or AML allowed
* More than 6 months since prior decitabine, azacitidine, or bortezomib
* No concurrent palliative radiotherapy
* No other concurrent investigational agents
* No other concurrent direct anti-leukemia therapy