Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia
Recruitment status was Recruiting
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.
Drug: daunorubicin hydrochloride
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study Evaluating the Chemosensitizing Effect of Everolimus Administered With Cytarabine and Daunorubicin in Patients With Acute Myeloid Leukemia in Relapse|
- Maximum tolerated dose of everolimus [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Activation of PI3K/AKT and mTORC 1 in leukemic blasts [ Designated as safety issue: No ]
- Pharmacokinetics of everolimus [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
- 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.
|Paris, France, 75674|
|Contact: Sophie Park, MD 33-140-514-543|
|Investigator:||Sophie Park, MD||Institut de Recherches sur les Leucemies et les Maladies du Sang|