Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098826
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
2004-12-08
Brief Title:
SB-715992 in Treating Patients With Acute Leukemia Chronic Myelogenous Leukemia or Advanced Myelodysplastic Syndromes
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Pharmacodynamic Study of SB-715992 in Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of SB-715992 in treating patients who have acute leukemia chronic myelogenous leukemia or advanced myelodysplastic syndromes Drugs used in chemotherapy such as SB-715992 work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of SB-715992 given as a daily x 3 infusion in patients with acute leukemia
II To obtain pharmacokinetic studies of SB-715992 given on a 3 consecutive day schedule every 3 weeks
III To describe treatment-related and dose-limiting toxicities of SB-715992 in patients with acute leukemia
IV To describe the anti-leukemia activity of SB-715992 V To correlate treatment-related toxicities with pharmacokinetic studies of SB-715992
SECONDARY OBJECTIVES
I To validate KSP as the major target of SB-715992 by determining the impact of drug treatment on cytoskeletal morphology in peripheral blood mononuclear cells and circulating leukemic blasts
II To determine the expression of tubulin isoforms and KSP in leukemic blasts and explore possible relationships between gene expression and response to SB-715992
OUTLINE This is a dose-escalation multicenter study
Induction chemotherapy Patients receive SB-715992 IV over 1 hour on days 1-3 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Consolidation chemotherapy Patients achieving complete response CR partial response PR or stable disease SD after induction chemotherapy receive up to 4 additional courses of SB-715992 beyond CR PR or SD
Cohorts of 3-6 patients receive SB-715992 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 9 patients are treated at the MTD
Patients are followed for 6 weeks
PROJECTED ACCRUAL Approximately 15-30 patients will be accrued for this study within 75-15 months
I To determine the maximum tolerated dose MTD of SB-715992 given as a daily x 3 infusion in patients with acute leukemia
II To obtain pharmacokinetic studies of SB-715992 given on a 3 consecutive day schedule every 3 weeks
III To describe treatment-related and dose-limiting toxicities of SB-715992 in patients with acute leukemia
IV To describe the anti-leukemia activity of SB-715992 V To correlate treatment-related toxicities with pharmacokinetic studies of SB-715992
SECONDARY OBJECTIVES
I To validate KSP as the major target of SB-715992 by determining the impact of drug treatment on cytoskeletal morphology in peripheral blood mononuclear cells and circulating leukemic blasts
II To determine the expression of tubulin isoforms and KSP in leukemic blasts and explore possible relationships between gene expression and response to SB-715992
OUTLINE This is a dose-escalation multicenter study
Induction chemotherapy Patients receive SB-715992 IV over 1 hour on days 1-3 Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity
Consolidation chemotherapy Patients achieving complete response CR partial response PR or stable disease SD after induction chemotherapy receive up to 4 additional courses of SB-715992 beyond CR PR or SD
Cohorts of 3-6 patients receive SB-715992 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 9 patients are treated at the MTD
Patients are followed for 6 weeks
PROJECTED ACCRUAL Approximately 15-30 patients will be accrued for this study within 75-15 months
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 |
|---|---|---|---|
| U01CA062505 | NIH | None | httpsreporternihgovquickSearchU01CA062505 |
| CASE 3904 | None | None | None |
| U01CA062502 | NIH | None | None |