Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00544999|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : October 16, 2007
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Drug: cytarabine Drug: daunorubicin hydrochloride Drug: everolimus Other: laboratory biomarker analysis Other: pharmacological study||Phase 1|
- Determine the maximum tolerated dose of everolimus.
- Determine the toxicity of this regimen.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Official Title:||Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse|
|Study Start Date :||September 2007|
|Estimated Primary Completion Date :||April 2010|
- Maximum tolerated dose of everolimus
- Activation of PI3K/AKT and mTORC 1 in leukemic blasts
- Pharmacokinetics of everolimus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544999
|Paris, France, 75674|
|Contact: Sophie Park, MD 33-140-514-543|
|OverallOfficial:||Sophie Park, MD||Institut de Recherche Clinique sur les Cancers et le Sang|