Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia

Phase 1

• Conditions: Leukemia

• Registration Number: NCT00544999
• Lead Sponsor: Institut de Recherche Clinique sur les Cancers et le Sang

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Everolimus may help cytarabine and daunorubicin work better by making cancer cells more sensitive to chemotherapy. Giving everolimus together with cytarabine and daunorubicin may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of everolimus when given together with cytarabine and daunorubicin in treating patients with relapsed acute myeloid leukemia.

Detailed Description

OBJECTIVES:

Primary

* Determine the maximum tolerated dose of everolimus.

* Determine the toxicity of this regimen.

Secondary

* Assess the activation of PI3K/AKT and mTORC 1 in leukemic blasts.

* Evaluate the pharmacokinetics of everolimus at different concentrations.

OUTLINE: This is a multicenter study.

Patients receive primary induction therapy comprising daunorubicin hydrochloride IV on days 1-3, cytarabine IV over 24 hours on day 1, and oral everolimus on days 1 and 7. Patients with more than 5% blasts on day 15 receive a second induction course comprising daunorubicin hydrochloride IV on days 17 and 18 and cytarabine IV twice daily on days 17-20.

After completion of study therapy, patients are followed for 3 months.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-13
• Study First Submitted QC: 2007-10-13
• Study First Posted: 2007-10-16
• Status Verified: 2009-07
• Primary Completion: 2010-04
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of everolimus
Toxicity

Secondary Outcome Measures

Name	Time	Method
Activation of PI3K/AKT and mTORC 1 in leukemic blasts
Pharmacokinetics of everolimus

Trial Locations

Locations (1)

Hopital Cochin; 🇫🇷 Paris, France