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

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ClinicalTrials.gov Identifier: NCT01150669
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

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.

Condition or disease Intervention/treatment
Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Other: laboratory biomarker analysis

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.


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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: SCOR in Targeted Therapies for Infant Leukemia Project 3: Targeting FLT3 in Infant Leukemia
Study Start Date : July 2010
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


Group/Cohort Intervention/treatment
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.
Other: laboratory biomarker analysis
Samples are analyzed in laboratory studies




Primary Outcome Measures :
  1. Expression level and activation state of FLT3 protein, determined by Western blotting and FACS [ Time Frame: Up to 4 months ]
  2. TKI sensitivity, determined by MTT and annexin V assays [ Time Frame: Up to 4 months ]
  3. Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies [ Time Frame: Baseline ]
  4. 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 [ Time Frame: Up to 4 months ]


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from infants with leukemia
Criteria

Inclusion Criteria:

  • Cryopreserved samples from infants with leukemia available

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150669


Locations
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United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Patrick Brown, MD Children's Oncology Group

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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01150669     History of Changes
Other Study ID Numbers: AAML10B18
NCI-2011-02240 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-AAML10B18 ( Other Identifier: Children's Oncology Group )
CDR0000675724 ( Other Identifier: Clinical Trials.gov )
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid, Acute
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases