Evaluating Cell Damage in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndromes, or Fanconi Anemia; in Patients Who Were Exposed to Alkylating Agents; and in Healthy Volunteers

This study has been terminated.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00899795
First received: May 9, 2009
Last updated: May 24, 2012
Last verified: February 2011
  Purpose

RATIONALE: Studying samples of bone marrow from patients with cancer and from healthy volunteers in the laboratory may help doctors learn more about changes that occur in bone marrow stromal (connective tissue) cells. It may also help doctors understand the effects of alkylating agents on bone marrow stromal cells.

PURPOSE: This laboratory study is evaluating stromal cells in patients with acute myeloid leukemia, myelodysplastic syndromes, or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.


Condition Intervention
Leukemia
Myelodysplastic Syndromes
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Other: flow cytometry
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Stromal Injury and Clonal Adaptation in Myelodysplasia

Resource links provided by NLM:


Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Abnormal stromal function [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clonal progenitors resistant to selected extracellular apoptotic cells [ Designated as safety issue: No ]
  • Comparison of stromal function between secondary vs primary acute myeloid leukemia or myelodysplastic syndromes [ Designated as safety issue: No ]
  • Influence of cytotoxic agents on supportive function of the bone marrow stroma [ Designated as safety issue: No ]
  • Reduction of cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells with use of cytoprotective agents [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

Primary

  • Determine abnormal stromal function in patients with acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), or Fanconi anemia; in patients who were exposed to alkylating agents; and in healthy volunteers.

Secondary

  • Determine whether clonal progenitors from patients with secondary AML or MDS are resistant to selected extracellular apoptotic cues.
  • Determine whether stromal function in patients with secondary AML or MDS is more aberrant than stromal function in patients with primary AML or MDS.
  • Determine whether cytotoxic agents known to induce secondary MDS or AML influence the supportive function of the bone marrow stroma.
  • Determine whether cytoprotective agents reduce both cytotoxicity and genotoxicity in hematopoietic progenitor cells and stromal cells.

OUTLINE: Patients and healthy volunteers undergo bone marrow sample collection. Progenitor cells are grown in culture. Cell survival is quantified by flow cytometric and cytogenetic analysis, sister chromatid exchange, and FISH for chromosome 11 changes (for etoposide-exposed samples only).

PROJECTED ACCRUAL: A total of 24 patients and healthy volunteers will be accrued for this study.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inpatient, outpatient, and normal volunteers

Criteria

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of acute myeloid leukemia or myelodysplastic syndromes and requires bone marrow aspiration/biopsy for clinical purposes

      • Primary or secondary disease
    • Diagnosis of Fanconi anemia by positive mitomycin C test (age 5 to 55 years)
    • Received prior chemotherapy containing any of the following alkylating agents: mechlorethamine, chlorambucil, cyclophosphamide, melphalan, busulfan, or topoisomerase inhibitors
    • Healthy volunteer (age 18 and over), meeting the following criteria:

      • CBC normal
      • WBC > 1,000/mm³
      • Hemoglobin > 10 g/dL
      • Platelet count > 70,000/mm³
  • No bone marrow metastases
  • No evidence of non-hematopoietic malignancy

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • No clinical signs and symptoms of acute or subacute infection (viral, bacterial, or fungal infection)
  • No allergy to lidocaine or xylocaine

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 6 months since prior cytotoxic or immunosuppressive agents
  • No prior extensive pelvic radiotherapy (> 20 Gy)
  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: NCT00899795

Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Grover C. Bagby, MD OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00899795     History of Changes
Other Study ID Numbers: CDR0000445436, P30CA069533, OHSU-HEM-02008-LX
Study First Received: May 9, 2009
Last Updated: May 24, 2012
Health Authority: United States: Federal Government

Keywords provided by OHSU Knight Cancer Institute:
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
de novo myelodysplastic syndromes
previously treated myelodysplastic syndromes
recurrent adult acute myeloid leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
untreated adult acute myeloid leukemia
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014