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OpenTrials
Completed

NCT Number: NCT01395628

Cell Samples From Patients With Leukemia

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

in vitro sensitivity-directed chemotherapy

Drug

cell proliferation assay

Other

fluorescence activated cell sorting

Other

laboratory biomarker analysis

Other

microscopy

Other

Primary outcomes

  1. Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo

  2. In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells

  3. Effects of novel anticancer drugs and/or their combinations on individual samples

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Xenotransplantation of Primary Leukemia Samples Into Zebrafish

Important dates

Study start
2011
Primary completion
2016
First posted
Jul 15, 2011
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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