Ignite Creation Date:
2024-05-05 @ 10:39 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01150669
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2010-06-24
Brief Title:
Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
SCOR in Targeted Therapies for Infant Leukemia Project 3 Targeting FLT3 in Infant Leukemia
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells It may also help doctors identify biomarkers related to cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia
II Determine whether FLT3 protein expression level andor activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia
III Determine whether lestaurtinib activates STAT5 AKT and RAS-MAPK and other pathways
IV Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells
OUTLINE This is a multicenter study
Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents Samples are analyzed for FLT3 protein expression andor activation sensitivity to lestaurtinib with or without chemotherapy agents and activation of STAT AKT and RAS-MAPK and other pathways by western blot The most effective treatment from this study is then validated in vivo in a NODSCID xenograft model
I Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia
II Determine whether FLT3 protein expression level andor activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia
III Determine whether lestaurtinib activates STAT5 AKT and RAS-MAPK and other pathways
IV Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells
OUTLINE This is a multicenter study
Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents Samples are analyzed for FLT3 protein expression andor activation sensitivity to lestaurtinib with or without chemotherapy agents and activation of STAT AKT and RAS-MAPK and other pathways by western blot The most effective treatment from this study is then validated in vivo in a NODSCID xenograft model
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 |
|---|---|---|---|
| CDR0000675724 | OTHER | Clinical Trialsgov | None |
| NCI-2011-02240 | REGISTRY | None | None |
| COG-AAML10B18 | OTHER | None | None |