Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia

Childhood Acute Lymphoblastic Leukemia Clinical Trial

Official title:

SCOR in Targeted Therapies for Infant Leukemia Project 3: Targeting FLT3 in Infant Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150669
• Other study ID #: AAML10B18
• Secondary ID: NCI-2011-02240CO
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: May 17, 2016
• Start date: July 2010
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• Cryopreserved samples from infants with leukemia available

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia
• Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• laboratory biomarker analysis
Samples are analyzed in laboratory studies

Locations

Country	Name	City	State
United States	Children's Oncology Group	Monrovia	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expression level and activation state of FLT3 protein, determined by Western blotting and FACS		Up to 4 months	No
Primary	TKI sensitivity, determined by MTT and annexin V assays		Up to 4 months	No
Primary	Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies		Baseline	No
Primary	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	No