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

NCT ID: NCT01150669

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Observational

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.

laboratory biomarker analysis

Intervention Type OTHER

Samples are analyzed in laboratory studies

Interventions

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laboratory biomarker analysis

Samples are analyzed in laboratory studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Cryopreserved samples from infants with leukemia available
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Monrovia, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2011-02240

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-AAML10B18

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000675724

Identifier Type: OTHER

Identifier Source: secondary_id

AAML10B18

Identifier Type: -

Identifier Source: org_study_id

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