Decitabine and Bortezomib in Treating Patients With Acute Myeloid Leukemia

Completed · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT00703300

Run by

National Cancer Institute (NCI)

People needed

19

Starts

2008-06-01

Expected to finish

2014-10-01

Last updated by the study team

2014-11-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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