Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Children's Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01576185
First received: April 11, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

These laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.


Condition Intervention
Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Other: laboratory biomarker analysis
Drug: quizartinib
Drug: sorafenib tosylate

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Development of Pediatric Acute Myeloid Leukemia Xenograft Models for the Testing of Targeted Therapeutic Agents

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Engraftment ratio of human AML cells to murine cells [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    We will measure total leukemic burden from harvested femurs, tibias, and spleen by quantitative flow cytometry, estimate engraftment, and describe 95% confidence intervals. The total AML cell count of the control and treatment cohorts will be compared using an analysis of variance (ANOVA) test.

  • Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Primary Completion Date: January 2100 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational (xenograft models)
Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.
Other: laboratory biomarker analysis
Correlative studies
Drug: quizartinib
Via gavage
Other Names:
  • AC220
  • class III receptor tyrosine kinase inhibitor AC220
Drug: sorafenib tosylate
Via gavage
Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the rate of engraftment of pediatric FMS-Like Tyrosine Kinase-3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) samples in NOD scid gamma (NSG) mice.

II. To determine the efficacy of treatment of FLT3-ITD xenografts with tyrosine kinase inhibitors.

OUTLINE:

Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cryopreserved human AML samples FLT3-ITD samples with high allelic ratios

Criteria

Inclusion Criteria:

  • Cryopreserved human AML samples

    • FLT3-ITD samples with high allelic ratios
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576185

Locations
United States, California
Children's Oncology Group Recruiting
Arcadia, California, United States, 91006-3776
Contact: Sarah K. Tasian    877-827-3222    tasians@peds.ucsf.edu   
Principal Investigator: Sarah K. Tasian         
Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Sarah Tasian Children's Oncology Group
  More Information

No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01576185     History of Changes
Other Study ID Numbers: AAML12B8, NCI-2012-00724, COG-AAML12B8, CDR0000730390
Study First Received: April 11, 2012
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type
Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014