Clinical trial NCT01395628: Cell Samples From Patients With Leukemia
Official title: Xenotransplantation of Primary Leukemia Samples Into Zebrafish
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: chronic phase chronic myelogenous leukemia
childhood acute promyelocytic leukemia (M3)
childhood acute myeloid leukemia/other myeloid malignancies
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myeloid leukemia with del(5q)
adult acute promyelocytic leukemia (M3)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-15
Enrollment: 10
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with myeloid disease.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo
measure: In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells
measure: Effects of novel anticancer drugs and/or their combinations on individual samples
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Jason N. Berman, MD
role: PRINCIPAL_INVESTIGATOR
References: