Viewing Study NCT00042796



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Study NCT ID: NCT00042796
Status: TERMINATED
Last Update Posted: 2013-01-23
First Post: 2002-08-05

Brief Title: Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Sponsor: National Cancer Institute NCI
Organization: National Cancer Institute NCI

Study Overview

Official Title: A Phase I Study Of Decitabine DAC IND 50733 In Children With Relapsed Or Refractory Acute Leukemia
Status: TERMINATED
Status Verified Date: 2013-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Administratively complete
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die This phase I trial is studying the side effects and best dose of decitabine in treating children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia
Detailed Description: PRIMARY OBJECTIVES

I Determine the maximum tolerated dose of decitabine that is associated with consistent evidence of deoxyribonucleic acid DNA demethylation in children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia

II Determine the dose-limiting toxicity pharmacokinetics and antitumor activity of this drug in these patients

III Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing before and after treatment global and specific DNA methylation status using methylation microarrays and hemoglobin F levels in these patients

IV Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing before and after treatment global changes in gene expression profiles using cDNA microarrays and drug sensitivity of blast cells by MTT assays in these patients

V Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing before and after treatment deletions and single nucleotide polymorphisms in genomic DNA of deoxycytidine kinase and cytidine deaminase genes in these patients

VI Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing before and after treatment acetylation and methylation of histones H3 and H4 and helicase protein expression in these patients

OUTLINE This is a dose-escalation multicenter study Patients are stratified according to disease type acute myeloid leukemia vs acute lymphoblastic leukemia

Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 4-6 weeks for a minimum of 4 courses 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity

PROJECTED ACCRUAL A total of 15-21 patients will be accrued for this study within 75-21 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
CDR0000069471 REGISTRY PDQ Physician Data Query httpsreporternihgovquickSearchU01CA097452
ADVL0114 None None None
U01CA097452 NIH None None