Status:
COMPLETED
Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of bortezomib when given together with decitabine in treating patients with acute myeloid leukemia. Bortezomib may stop the growth of canc...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of bortezomib (Velcade, PS-341) in combination with decitabine in patients with acute myeloid leukemia (AML) II. To define the spe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00703300
Start Date
June 1 2008
End Date
October 1 2014
Last Update
November 7 2014
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210