Ignite Creation Date:
2024-05-05 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492401
Status:
COMPLETED
Last Update Posted:
2016-06-27
First Post:
2007-06-25
Brief Title:
Decitabine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Decitabine in Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-MSMS
After completion of study treatment patients are followed for at least 30 days
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-MSMS
After completion of study treatment patients are followed for at least 30 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM62207 | NIH | None | httpsreporternihgovquickSearchN01CM62207 |
| OSU 07017 | None | None | None |