Spots Global Cancer Trial Database for Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML

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Trial Identification

Brief Title: Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML

Official Title: Phase I Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)

Study ID: NCT00538876

Conditions

Acute Myeloid Leukemia

Interventions

decitabine

Study Description

Brief Summary: This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML. Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. Secondary Objectives: 1. To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML. 2. To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions. 3. To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.

Detailed Description: