Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-30 @ 5:48 PM
Study NCT ID:
NCT01150669
Status:
COMPLETED
Last Update Posted:
2016-05-18
First Post:
2010-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia
Sponsor:
Children's Oncology Group
Organization:
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 and/or 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 and/or 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 NOD/SCID 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 and/or 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 and/or 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 NOD/SCID xenograft model.
Study Oversight
Has Oversight DMC:
False
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?: