Cell Samples From Patients With Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01395628
First received: July 14, 2011
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Leukemia
Drug: in vitro sensitivity-directed chemotherapy
Other: cell proliferation assay
Other: fluorescence activated cell sorting
Other: laboratory biomarker analysis
Other: microscopy

Study Type: Observational
Official Title: Xenotransplantation of Primary Leukemia Samples Into Zebrafish

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Primary human leukemia samples capable to survive and proliferate in the zebrafish embryo [ Designated as safety issue: No ]
  • In vivo confirmation of anti-proliferative or toxic effects of known chemotherapeutic agents on the transplanted cells [ Designated as safety issue: No ]
  • Effects of novel anticancer drugs and/or their combinations on individual samples [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01395628

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Jason N. Berman, MD IWK Health Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01395628     History of Changes
Other Study ID Numbers: CDR0000703649, COG-AAML11B13
Study First Received: July 14, 2011
Last Updated: July 20, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)

Additional relevant MeSH terms:
Leukemia
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 30, 2014