Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053144
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2003-01-27
Brief Title:
Irinotecan and Cytarabine in Treating Patients With Refractory or Recurrent Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Irinotecan And Cytarabine In Refractory or Relapsed Acute Myeloid Leukemia And In Chronic Myelogenous Leukemia In Myeloid Blast Transformation Efficacy And In Vitro Correlates
Status:
COMPLETED
Status Verified Date:
2011-03
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 use different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia
PURPOSE Phase I trial to study the effectiveness of combining irinotecan with cytarabine in treating patients who have refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine the activity of irinotecan and cytarabine in patients with refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast transformation
Determine the pharmacokinetics of this regimen in these patients
Determine the maximum tolerated dose of irinotecan in this regimen in these patients
Correlate the clinical activity of this drug with cellular endpoints associated with DNA synthesis inhibition DNA repair induction of apoptosis and drug resistance in these patients
OUTLINE This is a dose-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days 1-6 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity An additional 9 patients with refractoryrelapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia in myeloid blast transformation are treated at the MTD
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 25 years
Determine the activity of irinotecan and cytarabine in patients with refractory or recurrent acute myeloid leukemia or chronic myelogenous leukemia in myeloid blast transformation
Determine the pharmacokinetics of this regimen in these patients
Determine the maximum tolerated dose of irinotecan in this regimen in these patients
Correlate the clinical activity of this drug with cellular endpoints associated with DNA synthesis inhibition DNA repair induction of apoptosis and drug resistance in these patients
OUTLINE This is a dose-escalation study of irinotecan
Patients receive irinotecan IV over 90 minutes and cytarabine IV over 60 minutes on days 1-6 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity An additional 9 patients with refractoryrelapsed acute myeloid leukemia and 9 patients with chronic myelogenous leukemia in myeloid blast transformation are treated at the MTD
Patients are followed for survival
PROJECTED ACCRUAL A total of 3-36 patients will be accrued for this study within 25 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 |
|---|---|---|---|
| RPCI-RPC-9901 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |