NCT00492401

Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia

Phase II Study of Decitabine in Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. 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

Detailed description

PRIMARY OBJECTIVES: I. Determine the rate of complete remission (CR) in patients with previously untreated acute myeloid leukemia treated with decitabine. SECONDARY OBJECTIVES: I. Determine the rate of overall survival at 1 year in patients treated with this drug. II. Determine the overall response rate (CR, incomplete CR, and partial remission) in patients treated with this drug. III. Correlate the biological activity of decitabine with clinical endpoints and maximum concentration of plasma decitabine. IV. Correlate intracellular concentration of decitabine with global DNA methylation, other biological endpoints, and clinical response. OUTLINE: Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and blood sample collection periodically for pharmacological and correlative studies. Samples are analyzed for gene expression, methylation of gene promoters, fetal hemoglobin (HgF), DNMT1 protein expression, maximum concentration of plasma decitabine, and global DNA methylation. Samples are analyzed by RT-PCR, Bio-COBRA, matrix-assisted laser desorption ionization time-of-flight mass spectrometry, SDS-PAGE (polyacrylamide gel electrophoresis), immunoblotting, and LC-MS/MS. After completion of study treatment, patients are followed for at least 30 days.

Conditions

• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• 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)
• Secondary Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	decitabine	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	pharmacological study	Correlative studies
OTHER	high performance liquid chromatography	Correlative studies
GENETIC	microarray analysis	Correlative studies
GENETIC	RNA analysis	Correlative studies
OTHER	mass spectrometry	Correlative studies
GENETIC	DNA methylation analysis	Correlative studies
OTHER	matrix-assisted laser desorption/ionization time of flight mass spectrometry	Correlative studies

Timeline

• Start date: 2007-05-01
• Primary completion: 2010-12-01
• Completion: 2014-10-01
• First posted: 2007-06-27
• Last updated: 2016-06-27
• Results posted: 2016-06-27

Locations

1 site across 1 country: United States