Viewing Study NCT00049582



Ignite Creation Date: 2024-05-05 @ 11:26 AM
Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00049582
Status: TERMINATED
Last Update Posted: 2013-09-30
First Post: 2002-11-12

Brief Title: Decitabine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: Phase I Study of 5-Aza-2-Deoxycytidine Decitabine as a Biologic Modifier of Retinoid Responsive Genes in Patients With High-Risk Myelodysplastic Syndromes and Acute Myelogenous Leukemia De-novo Relapsed or Secondary
Status: TERMINATED
Status Verified Date: 2013-09
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 I trial is studying the side effects and best dose of decitabine in treating patients with myelodysplastic syndromes or acute myeloid leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description: OBJECTIVES

I Determine the maximum tolerated dose of decitabine in patients with high-risk myelodysplastic syndromes or acute myeloid leukemia

II Determine the minimum effective dose of this drug that produces demethylation of DNA with tolerable toxicity in these patients

III Determine the minimum effective dose of this drug that augments in vitro responses to retinoids

IV Determine the pharmacokinetics of this drug in these patients V Determine the clinical response rate of patients treated with this drug

OUTLINE This is a dose-escalation multicenter study

Patients receive decitabine IV over 3 hours twice daily OR IV over 1 hour once daily on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Cohorts of 3-6 patients receive escalating doses of decitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity

PROJECTED ACCRUAL A maximum of 36 patients will be accrued for this study within 18 months

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
N01CM62203 NIH CTEP httpsreporternihgovquickSearchN01CM62203
NCI-2012-02502 REGISTRY None None
CDR0000258121 None None None
NCI-5591 None None None
5591 OTHER None None
PHL-004 None None None
PHL-004 OTHER None None