Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With Hematologic Cancer and From Patients Who Do Not Have Cancer

Study of Natural Killer Cells in Bone Marrow and Blood Samples From Patients With Hematologic Cancer and From Patients Who Do Not Have Cancer
This study is currently recruiting participants.
Verified on July 2011 by Case Comprehensive Cancer Center

First Received on June 10, 2009.  
Last Updated on July 20, 2011  
History of Changes
Sponsor: Case Comprehensive Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00918658
  Purpose

RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors find better ways to treat the cancer.

PURPOSE: This research study is looking at natural killer cells in bone marrow and blood samples from patients with hematologic cancer and from patients who do not have cancer.

Condition Intervention
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Other: biologic sample preservation procedure
Other: immunologic technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Collection of Bone Marrow and Peripheral Blood for Testing of Notch-induced Natural Killer Cell Activity

Resource links provided by NLM:

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

  • Collection of normal and malignant cells to use as target cells in cytotoxicity assays [ Time Frame: We anticipate collecting approximately 30 samples in total, over a 1-2 year period. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

To collect normal and malignant cells in bone marrow and peripheral blood samples from patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma and from patients with no malignancy to use as target cells in cytotoxicity assays.

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts

Assigned Interventions
Patients with hematologic cancer

Patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma
Interventions:
  • Other: biologic sample preservation procedure
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
Other: biologic sample preservation procedure

All specimens will be collected using the Pathology Residual Tissue Procurement.

Other: immunologic technique

Information about HLA type and immunophenotype of the malignant cells is collected from the patient’s medical record.

Other: laboratory biomarker analysis

Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.
Patients without cancer

Patients who do not have cancer.
Interventions:
  • Other: biologic sample preservation procedure
  • Other: immunologic technique
  • Other: laboratory biomarker analysis
Other: biologic sample preservation procedure

All specimens will be collected using the Pathology Residual Tissue Procurement.

Other: immunologic technique

Information about HLA type and immunophenotype of the malignant cells is collected from the patient’s medical record.

Other: laboratory biomarker analysis

Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.

Detailed Description:

OBJECTIVES:

  • To collect normal and malignant cells in bone marrow and peripheral blood samples from patients with acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, or multiple myeloma and from patients with no malignancy to use as target cells in cytotoxicity assays.
  • To collect information about HLA type and immunophenotype of malignant cells as determined by clinical flow cytometry.

OUTLINE: Bone marrow aspirates and/or peripheral blood samples are collected and used as target cells in standard cytotoxicity assays, with notch-induced natural killer (N-NK) cells as the effector cells, to determine whether N-NK cells are capable of killing malignant cells and/or non-malignant cells. Receptor-blocking antibodies may be added to determine which NK cell receptors are responsible for malignant cell recognition and killing.

Information about HLA type and immunophenotype of the malignant cells is collected from the patient’s medical record.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

Criteria

DISEASE CHARACTERISTICS:

  • Meets one of the following criteria:

    • No evidence of malignancy
    • Diagnosis of one of the following:

      • Acute myeloid leukemia
      • Acute lymphoblastic leukemia
      • Chronic myelogenous leukemia
      • Multiple myeloma

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00918658

Contacts
Contact: Rose Beck, MD 216-368-2387 rose.beck@case.edu

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Rose Beck, MD, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:

No publications provided

Responsible Party: Rose Beck, MD, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00918658    
History of Changes
Other Study ID Numbers: CASE2Z08, P30CA043703, CASE2Z08, CASE-2Z08-CC502
Study First Received: June 10, 2009
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:

childhood chronic myelogenous leukemia
chronic myelogenous leukemia
adult acute lymphoblastic leukemia
childhood acute lymphoblastic leukemia
adult acute myeloid leukemia
childhood acute myeloid leukemia/other myeloid malignancies
multiple myeloma

Additional relevant MeSH terms:

Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on December 02, 2011

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