S0919 Idarubicin, Cytarabine, and Pravastatin in Treating Patients With Relapsed Acute Myeloid Leukemia
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Pravastatin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Pravastatin may also help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs. Giving idarubicin and cytarabine together with pravastatin may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving idarubicin and cytarabine together with pravastatin works in treating patients with relapsed acute myeloid leukemia.
Drug: pravastatin sodium
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||S0919, A Phase II Study of Idarubicin and Ara-C in Combination With Pravastatin for Relapsed Acute Myelogenous Leukemia (AML)|
- Complete remission (CR) rate (including CR with incomplete recovery) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Relapse-free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE version 4.0 [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Correlation between pre-study cytogenetic features and response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||November 2015|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Induction (1 cycle):
pravastatin 1280 mg/d PO D 1-8 idarubicin 12 mg/m2/d IV D 4-6 AraC 1.5 g/m2/d contIV D 4-7
Consolidation (up to 2 cycles):
pravastatin 1280 mg/d PO D 1-6 idarubicin 12 mg/m2/d IV D 4-5 AraC 1.5 g/m2/d contIV D 4-5
|Drug: cytarabine Drug: idarubicin Drug: pravastatin sodium|
- To test whether the complete remission (CR) rate (including CR with incomplete recovery) in patients with relapsed acute myeloid leukemia treated with idarubicin and cytarabine in combination with pravastatin is sufficiently high to warrant a phase III investigation.
- To estimate relapse-free survival and overall survival rates in these patients.
- To estimate the frequency and severity of toxicities of this regimen in these patients.
- To evaluate, in a preliminary manner, whether pre-study cytogenetic features correlate with response in these patients.
OUTLINE: This is a multicenter study.
- Induction therapy: Patients receive oral pravastatin once daily on days 1-8, idarubicin IV over 10-15 minutes on days 4-6, and cytarabine IV continuously on days 4-7. Patients achieving complete remission proceed to consolidation therapy.
- Consolidation therapy: Beginning 30-60 days after the start of induction therapy, patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 10-15 minutes and cytarabine IV continuously on days 4 and 5. Treatment repeats approximately every 5 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.