Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093483
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2004-10-06
Brief Title:
Arsenic Trioxide Cytarabine and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Arsenic Trioxide High-Dose Cytarabine and Idarubicin Induction Therapy in Previously Untreated de Novo and Secondary Adult Acute Myeloid Leukemia Patients 60 Years Old - A Phase I Study
Status:
COMPLETED
Status Verified Date:
2014-01
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 arsenic trioxide cytarabine and idarubicin work in 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 This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with cytarabine and idarubicin in treating patients with acute myeloid leukemia
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with cytarabine and idarubicin in treating patients with acute myeloid leukemia
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose andor biologically effective dose of arsenic trioxide followed by high-dose cytarabine and idarubicin in patients with previously untreated de novo or secondary acute myeloid leukemia
OUTLINE This is a dose-escalation study of arsenic trioxide Patients are stratified according to timing of accrual before November 2002 vs since November 2002
Patients receive arsenic trioxide IV over 1 hour on day 1 followed by high-dose cytarabine IV over 1 hour every 12 hours on days 1-6 and idarubicin IV over 30 minutes on days 2-4 immediately after doses 3 5 and 7 of cytarabine Patients also receive filgrastim G-CSF subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD current dose used for myelodysplastic syndromes or acute promyelocytic leukemia or biologically effective dose is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The biologically effective dose is defined as the dose at which 3 patients with constitutive STAT3 activity have the activity negated after the first dose of arsenic trioxide
PROJECTED ACCRUAL A maximum of 40 patients 6 for stratum I accrued before November 2002 and 34 for stratum II accrued since November 2002 will be accrued for this study within 3 years
Determine the maximum tolerated dose andor biologically effective dose of arsenic trioxide followed by high-dose cytarabine and idarubicin in patients with previously untreated de novo or secondary acute myeloid leukemia
OUTLINE This is a dose-escalation study of arsenic trioxide Patients are stratified according to timing of accrual before November 2002 vs since November 2002
Patients receive arsenic trioxide IV over 1 hour on day 1 followed by high-dose cytarabine IV over 1 hour every 12 hours on days 1-6 and idarubicin IV over 30 minutes on days 2-4 immediately after doses 3 5 and 7 of cytarabine Patients also receive filgrastim G-CSF subcutaneously beginning 12 hours after the last dose of chemotherapy and continuing until blood counts recover
Cohorts of 3-6 patients receive escalating doses of arsenic trioxide until the maximum tolerated dose MTD current dose used for myelodysplastic syndromes or acute promyelocytic leukemia or biologically effective dose is reached The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity The biologically effective dose is defined as the dose at which 3 patients with constitutive STAT3 activity have the activity negated after the first dose of arsenic trioxide
PROJECTED ACCRUAL A maximum of 40 patients 6 for stratum I accrued before November 2002 and 34 for stratum II accrued since November 2002 will be accrued for this study within 3 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-RP-0209 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016056 |
| P30CA016056 | NIH | None | None |