Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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 cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with decitabine may kill more cancer cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Azacitidine; Bortezomib; Decitabine

Criteria

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