Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Conditions
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.
Interventions
OTHERlaboratory biomarker analysis
Samples are analyzed in laboratory studies
Sponsors
National Cancer Institute (NCI)
Children's Oncology Group
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* Cryopreserved samples from infants with leukemia available
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression level and activation state of FLT3 protein, determined by Western blotting and FACS | Up to 4 months |
| TKI sensitivity, determined by MTT and annexin V assays | Up to 4 months |
| Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies | Baseline |
| Incidence of cell death in primary infant leukemia samples treated with sequenced combinations of chemotherapy and FLT3 TKI using MTT and annexin V binding assays and median effect analysis | Up to 4 months |
Countries
United States
Outcome results
None listed