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 - NCT00899795-97239(Clinical Trial 291432)
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Portland |
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State:
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OR |
| Zip Code: |
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97239 |
| Conditions: |
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Leukemia - Myelodysplastic Syndromes |
| Purpose: |
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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.
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| Study summary: |
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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. |
| Criteria: |
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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) |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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