Cell Samples From Patients With Leukemia

May 17, 2016 updated by: Children's Oncology Group

Xenotransplantation of Primary Leukemia Samples Into Zebrafish

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. It may also help doctors find better ways to treat cancer.

PURPOSE: This research trial is studying samples from patients with leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Demonstrate the capability of primary human leukemia samples to survive and proliferate in the zebrafish embryo.
  • Confirm the anti-proliferative or toxic effects of known chemotherapeutics on the transplanted cells in vivo.
  • Evaluate the effect of novel anticancer drugs and/or their combinations on individual samples.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are injected into the yolk sac of zebrafish embryos under anesthesia. After 1 hour of recovery at 28° C, embryos are maintained at 38° C and screened for fluorescence at the injection site. Within 48 hours post-injection, some embryos are treated with various chemotherapeutic drugs or dimethyl sulfoxide and incubated in protease solution. Proliferation of leukemia cells are monitored by live-cell microscopy. Cells with or without drug treatment are then extracted at 24 and 72 hours post-injection. Leukemia cells are counted and tested with imatinib mesylate, all-trans retinoic acid (tretinoin), cytosine arabinose, and known bioactive chemical compounds from promising drug families, such as tyrosine kinase inhibitors, antiapoptotic agents, channel modulators, and prostaglandin agonists.

Study Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with myeloid disease.

Description

DISEASE CHARACTERISTICS:

  • Samples of blood and tissue cells from patients diagnosed with myeloid disease including the following subtypes:

    • Chronic phase chronic myeloid leukemia (CML), to complement initial studies in the K562 CML cell line
    • Acute promyelocytic leukemia (APL), to complement initial studies in the NB4 APL cell line
    • Acute myeloid leukemia (AML) expressing the t(8;21)(q22;q22) translocation, which occurs in approximately 12% of pediatric AML and is associated with good prognosis
    • AML expressing 5q- or monosomy 7, associated with a poor prognosis
    • AML expressing the fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), associated with a poor prognosis

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo
In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells
Effects of novel anticancer drugs and/or their combinations on individual samples

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jason N. Berman, MD, IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 14, 2011

First Submitted That Met QC Criteria

July 14, 2011

First Posted (Estimate)

July 15, 2011

Study Record Updates

Last Update Posted (Estimate)

May 19, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML11B13 (Other Identifier: Children's Oncology Group)
  • COG-AAML11B13 (Other Identifier: Children's Oncology Group)
  • NCI-2011-02863 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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