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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Notify MeKey information
Conditions
Age range
Up to 30 year
Sex eligibility
All sexes
Study type
Observational
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
cell proliferation assay
Otherfluorescence activated cell sorting
Otherlaboratory biomarker analysis
Othermicroscopy
OtherPrimary outcomes
-
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
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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