Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107523
Status:
COMPLETED
Last Update Posted:
2010-09-21
First Post:
2005-04-05
Brief Title:
Pravastatin Idarubicin and Cytarabine in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Phase I Trial Evaluating the Effect of the Addition of HMGCoA-Reductase Inhibition With Pravastatin to Salvage Chemotherapy Idarubicin-HDAC in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2010-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 help idarubicin and cytarabine work better by making cancer cells more sensitive to the drugs Giving pravastatin together with idarubicin and cytarabine may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of pravastatin when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of pravastatin when given together with idarubicin and cytarabine in treating patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the biological efficacy of pravastatin in leukemia cells in terms of measuring surrogate endpoints including cellular cholesterol messenger RNA encoding cholesterol synthesis cholesterol import regulators and specific protein farnesylation in patients with acute myeloid leukemia
Determine whether increasing doses of pravastatin when administered with idarubicin and high-dose cytarabine produce increased apoptosis in leukemia cells of these patients
Determine the maximum tolerated dose MTD of pravastatin when administered with idarubicin and high-dose cytarabine in these patients
Determine whether the MTD of pravastatin is required to achieve the maximal biological effect on cholesterol metabolism in leukemia cells of these patients
OUTLINE This is an open-label multicenter dose-escalation study of pravastatin
Patients receive oral pravastatin once daily on days 1-8 idarubicin IV over 30 minutes on days 4-6 and high-dose cytarabine IV continuously on days 4-7 Treatment repeats every 28-42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR may receive additional treatment with the same doses of study drugs over fewer days These patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 30 minutes and high-dose cytarabine IV continuously on days 4 and 5 Patients experiencing disease response with severe side effects may receive additional treatment at a lower dose of the study drug causing the side effects
Cohorts of 3 patients receive escalating doses of pravastatin until the maximum tolerated dose MTD is determined or a predetermined maximum dose is reached
NOTE Patients achieving a CR with a dose of pravastatin that is subsequently determined to be above the MTD receive pravastatin at the MTD for all subsequent courses
After completion of study treatment patients are followed at least every 3 months for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 2 years
Determine the biological efficacy of pravastatin in leukemia cells in terms of measuring surrogate endpoints including cellular cholesterol messenger RNA encoding cholesterol synthesis cholesterol import regulators and specific protein farnesylation in patients with acute myeloid leukemia
Determine whether increasing doses of pravastatin when administered with idarubicin and high-dose cytarabine produce increased apoptosis in leukemia cells of these patients
Determine the maximum tolerated dose MTD of pravastatin when administered with idarubicin and high-dose cytarabine in these patients
Determine whether the MTD of pravastatin is required to achieve the maximal biological effect on cholesterol metabolism in leukemia cells of these patients
OUTLINE This is an open-label multicenter dose-escalation study of pravastatin
Patients receive oral pravastatin once daily on days 1-8 idarubicin IV over 30 minutes on days 4-6 and high-dose cytarabine IV continuously on days 4-7 Treatment repeats every 28-42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving a complete remission CR may receive additional treatment with the same doses of study drugs over fewer days These patients receive oral pravastatin once daily on days 1-6 and idarubicin IV over 30 minutes and high-dose cytarabine IV continuously on days 4 and 5 Patients experiencing disease response with severe side effects may receive additional treatment at a lower dose of the study drug causing the side effects
Cohorts of 3 patients receive escalating doses of pravastatin until the maximum tolerated dose MTD is determined or a predetermined maximum dose is reached
NOTE Patients achieving a CR with a dose of pravastatin that is subsequently determined to be above the MTD receive pravastatin at the MTD for all subsequent courses
After completion of study treatment patients are followed at least every 3 months for 2 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000419678 | REGISTRY | PDQ | None |
| FHCRC-194500 | None | None | None |
| MDA-2004-0185 | None | None | None |